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Re^/KF M/74-3^/.^2,//V(b7 \nclex: tab^e G The RECEIVED 'SEP i^ 1993 LAW LIBRARY NORTH CAROLINA {± REGISTER IN TfflS ISSUE EXECUTIVE ORDER ITJTM hriow y PROPOSED RULES Administration Environment, Health, and Natural Resources Human Resources Insurance Justice Refrigeration Examiners State Treasurer Transportation RRC OBJECTIONS RULES INVALIDATED BY JUDICIAL DECISION CONTESTED CASE DECISIONS ISSUE DATE: September 15, 1993 Volume 8 • Issue 12 • Pages 1007 - 1184 INFORMATION ABOUT THE NORTH CAROLINA REGISTER AND ADMTNTSTRATTVE CODE NORTH CAROLINA REGISTER TEMPORARY RULES The North Carolina Register is published twice a month and contains information relating to agency, executive, legislative and judicial actions required by or affecting Chapter 150B of the Genera] Statutes. All proposed administrative rules and notices of public hearings filed under G.S. 150B-21.2 must be published in the Register. The Register will typically comprise approximately fifty pages per issue of legal text. State law requires that a copy of each issue be provided free of charge to each county in the state and to various state officials and institutions. The North Carolina Register is available by yearly subscription at a cost of one hundred and five dollars (S105.00) for 24 issues. Individual issues may be purchased for eight dollars (S8.00). Requests for subscription to the North Carolina Register should be directed to the Office of Administrative Hearings, P. 0. Drawer 27447, Raleigh, N. C. 2761 1-7447. Under certain emergency conditions, agencies may issue temporary rules. Within 24 hours of submission to OAH, the Codifier of Rules must review the agency's written statement of findings of need for the temporary rule pursuant to the provisions in G.S. 150B-21.1. If the Codifier determines that the findings meet the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If the Codifier determines that the fmdings do not meet the criteria, the rule is returned to the agency. The agency may supplement its findings and resubmit the temporary rule for an additional review or the agency may respond that it will remain with its initial position. The Codifier, thereafter, will enter the rule into the NCAC. A temporary rule becomes effective either when the Codifier of Rules enters the rule in the Code or on the sixth business day after the agency resubmits the rule without change. The temporary rule is in effect for the period specified in the rule or 180 days, whichever is less. An agency adopting a temporary rule must begin rule-making procedures on the permanent rule at the same time the temporary rule is filed with the Codifier. ADOPTION AMENDMENT, AND REPEAL OF RULES NORTH CAROLINA ADMINISTRATIVE CODE TTie following is a generalized statement of the procedures to be followed for an agency to adopt, amend, or repeal a rule. For the specific statutory authority, please consult Article 2A of Chapter 150B of the General Statutes. Any agency intending to adopt, amend, or repeal a rule must first publish notice of the proposed action in the North Carolina Register. The notice must include the time and place of the public hearing (or instructions on how a member of the public may request a hearing); a statement of procedure for public comments; the text of the proposed rule or the statement of subject matter; the reason for the proposed action; a reference to the statutory authority for the action and the proposed effective date. Unless a specific statute provides otherwise, at least 15 days must elapse following publication of the notice in the North Carolina Register before the agency may conduct the public hearing and at least 30 days must elapse before the agency can take action on the proposed rule. An agency may not adopt a rule that differs substantially from the proposed form published as part of the public notice, until the adopted version has been published in the North Carolina Register for an additional 30 day comment period. When final action is taken, the promulgating agency must file the rule with the Rules Review Commission (RRC). After approval by RRC, the adopted rule is filed with the Office of Administrative Hearmgs (OAH). A rule or amended rule generally becomes effective 5 business days after the rule is filed with the Office of Administrative Hearings for publication in the North Carolina Administrative Code (NCAC). Proposed action on rules may be withdrawn by the promulgatmg agency at any time before final action is taken by the agency or before filing with OAH for publication in the NCAC. The North Carolina Administrative Code (NCAC) is a compilation and index of the administrative rules of 25 state agencies and 38 occupational licensing boards. The NCAC comprises approximately 15,000 letter size, single spaced pages of material of which approximately 35% of is changed annually. Compilation and publication of the NCAC is mandated bv G.S. 150B-21.18. The Code is divided into Titles and Chapters. Each state agency is assigned a separate title which is further broken down by chapters. Title 21 is designated for occupational licensing boards. The NCAC is available in two formats. (1) Single pages may be obtained at a minimum cost of two dollars and 50 cents (S2.50) for 10 pages or less, plus fifteen cents (50.15) per each additional page. (2) The full publication consists of 53 volumes, totaling in excess of 15.000 pages. It is supplemented monthly with replacement pages. A one year subscription to the full publication including supplements can be purchased for seven hundred and fifty dollars (S750.00). Individual volumes may also be purchased with supplement service. Renewal subscriptions for supplements to the initial publication are available. Requests for pages of rules or volumes of the NCAC should be directed to the Office of Administrative Hearings. CITATION TO THE NORTH CAROLINA REGISTER The North Carolina Register is cited by volume, issue, page number and date. 1:1 NCR 101-201, April 1, 1986 refers to Volume 1, Issue 1, pages 101 through 201 of the North Carolina Register issued on April 1, 1985. FOR INFORMATION CONTACT: Office of Administrative Hearings. ATTN: Rules Division, P.O. Drawer 27447, Raleigh. North Carolina 27611-7447, (919) 733-2678. NORTH CAROLINA REGISTER Office of Administrative Hearings P. O. Drawer 27447 Raleigh, North Carolina 27611-7447 (919) 733-2678 Julian Mann III, Director James R. Scarcella Sr., Deputy Director Molly Masich, Director ofAPA Services Staff: Ruby Creech, Publications Coordinator Teresa Kilpatrick, Editorial Assistant Jean Shirley, Editorial Assistant ISSUE CONTENTS I. EXECUTIVE ORDER Executive Order 23 1007 11. PROPOSED RULES Administration State Employees Combined Campaign 1008 Environment, Health, and Natural Resources Health Services 1098 Human Resources Facility Services 1014 Mental Health, Developmental Disabilities and Substance Abuse Services 1086 Social Services 1091 Insurance Financial Evaluation Division . . . 1093 Life and Health Division 1094 Special Services Division 1096 Justice Departmental Rules 1096 Licensing Board Refrigeration Examiners 1148 State Treasurer Retirement System 1146 Transportation Motor Vehicles, Division of ... . 1145 III. RRC OBJECTIONS 1151 IV. RULES INVALIDATED BY JUDICIAL DECISION 1155 V. CONTESTED CASE DECISIONS Index to ALJ Decisions 1156 Text of Selected Decisions 92 OSP 1606 1163 93 HRC 0167 11^ 93 CPS0205 1171 93 EHR0276 1176 VI. CUMULATIVE INDEX 1182 NORTH CAROLINA REGISTER Publication Schedule (July 1993 - May 1994) Volume and Issue Number Issue Date Last Day for Filing Last Day for Elec-tromc Filmg Earliest Date for PubUc Hearing 15 days from notice * End of Required Comment Penod 30 days from notice Iflst Day to Submit to RRC ** Earliest Effective Date 8:7 07/01/93 06/10/93 06/17/93 07/16/93 08/02/93 08/20/93 10/01/93 8:8 07/15/93 06/23/93 06/30/93 07/30/93 08/16/93 08/20/93 10/01/93 8:9 08/02/93 07/12/93 07/19/93 08/17/93 09/01/93 09/20/93 11/01/93 8:10 08/16/93 07/26/93 08/02/93 08/31/93 09/15/93 09/20/93 11/01/93 8:11 09/01/93 08/11/93 08/18/93 09/16/93 10/01/93 10/20/93 12/01/93 8:12 09/15/93 08/24/93 08/31/93 09/30/93 10/15/93 10/20/93 12/01/93 8:13 10/01/93 09/10/93 09/17/93 10/18/93 11/01/93 11/22/93 01/04/94 8:14 10/15/93 09/24/93 10/01/93 11/01/93 11/15/93 11/22/93 01/04/94 8:15 11/01/93 10/11/93 10/18/93 11/16/93 12/01/93 12/20/93 02/01/94 8:16 11/15/93 10/22/93 10/29/93 11/30/93 12/15/93 12/20/93 02/01/94 8:17 12/01/93 11/05/93 11/15/93 12/16/93 01/03/94 01/20/94 03/01/94 8:18 12/15/93 11/24/93 12/01/93 12/30/93 01/14/94 01/20/94 03/01/94 8:19 01/03/94 12/08 '93 12/15/93 01/18/94 02/02/94 02/21/94 04/01/94 8:20 01/14/94 12/21/93 12/30/93 01/31/94 02/14/94 02/21/94 04/01/94 8:21 02/01/94 01/10/94 01/18/94 02/16/94 03/03/94 03/21/94 05/01/94 8:22 02/15/94 01/25/94 02/10/94 03/02/94 03/17/94 03/21/94 05/01/94 8:23 03/01/94 02/08/94 02/15/94 03/16/94 03/31/94 04/20/94 06/01/94 8:24 03/15/94 02/22/94 03/10/94 03/30/94 04/14/94 04/20/94 06/01/94 9:1 04/04/94 03/11/94 03/18/94 04/19/94 05/04/94 05/20/94 07/01/94 9:2 04/15/94 03/24/94 03/31/94 05/02/94 05/16/94 05/20/94 07/01/94 9:3 05/02/94 04/11/94 04/18/94 05/17/94 06/01/94 06/20/94 08/01/94 9:4 05/16/94 04/25/94 05/02/94 05/31/94 06/15/94 06/20'94 08/01/94 Note: Time is computed according to the Rules of Civil Procedure, Rule 6. * An agency must accept comments for at least 30 days after the proposed text is published or until the date of any public hearing, whichever is longer. See G.S. 150B-21. 2(f) for adoption procedures. ** The "Earliest Effective Date " is computed assuming that the agency follows the publication schedule above, that the Rules Re\ie^v Commission approves the rule at the next calendar month meeting after submission, and that RRC delivers the rule to the Codifier of Rules five (5j business days before the 1st business day of the next calendar month. Rexised 07/93 EXECUTIVE ORDER EXECUTIVE ORDER NUMBER 23 PUBLIC SCHOOL ADMINISTRATOR TASK FORCE WHEREAS, this Administration has a goal of doing more with less in our public schools by increasing effectiveness and efficiency; WHEREAS, business and industry leaders have built up valuable expertise in using this strategy; WHEREAS, the most effective and efficient ratio of local public school administrators to teachers and students is not icnown; NOW, THEREFORE, by the power vested in me as Governor by the Constitution and laws of North Carolina, IT IS ORDERED: Section 1. Recission of Executive Order. Executive Order 12, dated May 12, 1993, hereby rescinded. IS (b) Section 2. Establishment. There is hereby established a Public School Administrator Task Force ("Task Force"). Section 3. Membership and Chair. The Task Force shall consist of the following members: (a) twelve business and industry leaders with experience in improving effectiveness and efficiency in their organizations appointed by the Governor; nine representatives of the public school system, appointed by the Governor, consisting of: three superintendents, three principals, and three teachers. A small, medium, and large public school system shall be represented in each cate-gory; the Director of State Personnel, or his designee; the State Auditor, or his designee; the Superintendent of Public Instruction, or his designee; and the State Budget Officer, or his designee. (c) (d) (e) (f) school administrators to teachers and students; (b) Determine the ratio necessary to effec-tively and efficiently administer quality education at the local level; (c) Develop guidelines for local public school administrators to follow in imple-menting more effective and efficient administration; and (d) Report its findings and recommendations to the Joint Legislative Education Over-sight Committee and to the State Board of Education by May 1, 1994. Section 5. Administration and Expenses. The Task Force members shall be reimbursed for reasonable travel and other expenses as allowed by North Carolina law. Administrative and staff support for the Task Force shall be principally provided by the Office of the Governor. Addition-al staff support may be provided by other state agencies as required. This order is effective immediately, and shall terminate upon completion of the Task Force's reported findings and recommendations. Done in the Capital City of Raleigh, North Carolina, this 26th day of August, 1993. The chair shall be designated by the Governor, and the Task Force shall meet at the call of the Chair. Section 4. Duties. The Task Force shall have the following duties: (a) Analyze existing ratios of local public 8:12 NORTH CAROLINA REGISTER September 15, 1993 1007 PROPOSED RULES TITLE 1 - DEPARTMENfT OF ADMINISTRATION ISotice is hereby given in accordance with G.S. 150B-21.2 that the State Employees Combined Campaign Advisory Committee intends to amend rules cited as 1 NCAC 35 .0101 - .0103, .0201 - .0204, .0301 - .0307 and repeal rule cited as 1 NCAC 35 . 0303. Existing Rules 1 NCAC 35 . 0301 - .0302, .0401 - .0407 are proposed to be recodi-fied as .0203 - .0204, .0301 - .0307. This notice reflects those recodification changes. A he proposed effective date of this action is December 1. 1993. Ike public hearing will be conducted at 10:00 a.m. on October 4, 1993 at the State Library Building, Room 211, 109 East Jones Street, Ra-leigh, NC ixeason for Proposed Action: To clarify and consolidate rules applying to charitable organiza-tions applying for inclusion in the State Employees Combined Campaign. i^omment Procedures: Written comments should be submitted to: Secretary Betty Ray McCain, Department of Cultural Resources, 109 East Jones Street, Raleigh, NC 27603. CHAPTER 35 - STATE EMPLOYEES COMBINED CAMPAIGN SECTION .0100 - PURPOSE AND ORGANIZATION .0101 DEFINITIONS The puqjoso of the State Employees Combinod Campaign ia to allow state employees the opportu nity to contribute to charitable non partisan organ! zations in an orderly and uniform process.—The contributions are in turn granted to tho se charities selected by the S.E.C.C. Advisory Committee. These Regulations apply only to those campaigns in which employees are asked to malce charitable donations using payroll deduct ion as method of payment. (a) "Charitable organization." A non-partisan organization that is tax-exempt for both the IRS and N.C. tax purposes. The organization must receive contributions that are tax deductible by the donor. (b) "Audit" or "audited financial statement." An examination of financial statements of an organiza-tion b^ a CPA. conducted in accordance with generally accepted auditing standards, to determine whether, in the CPAs opinion, the statements conform with generally accepted accounting principles or, if applicable, with another compre-hensive basis of accounting. (c) "State Employees Combined Campaign" or "SECC. " The official name of the state employees charitable fund-raising drive. (d) "Federation" or "Federated Group" means a group of voluntary charitable human health and welfare agencies organized for purposes of supply-ing common fund-raising, administrative, and management services to its constituent members. Statutory Authority G.S. 143-3.3; 143B-10. .0102 PURPOSE The official name of the state employoco charita feie — fundmising—drive — te—tbe — State — Employees Combined Campaign (SECC). The purpose of the State Employees Combined Campaign is to allow state employees the opportu-nity to contribute to charitable non-partisan organi-zations in an orderly and uniform process. The contributions are in turn granted to those charities selected by the SECC Advisory Committee. The SECC is authorized to conduct a payroll deduction fund-raising effort among state employees. Statutory Authority G.S 143-3.3: 143B-10. .0103 ORGANIZATION OF THE CAMPAIGN The Campaign Organization is as follows: (I) Chair. Each year the governor Governor may appoint a State Statewide Combined Campaign Director Chair from one of the Executive Cabinet^^ Council of State, System of Community Colleges, or Uni-versity Administration agencies. The Campaign Director Chair or the Cam-paign Director's Chair's designee will serve as chair director of the campaign. The responsibilities of the chair Chair include setting the dates and approving the published materials for the Combined Campaign, contracting for the Statewide Campaign Manager, and appointing and serving as chair of the S.E.C.C. advisory committee SECC Advisory Committee . 1008 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES For the purposes of selecting a Statewide Campaign Manager, the Statewide Com-bined Campaign Chair will consider the following criteria: (a) The organization must have demonstrat-ed ability to manage large-scale fund-raising campaigns. (b) The organization must have the ability and willingness to work with a state-wide system of local organizations capable of effectively managing local combined campaigns and relating to the Statewide Campaign Manager. (c) The organization must have an accept-able record of financial accountability. (d) The organization must be a tax-exempt organization under the Internal Revenue Code. (e) The organization must be willing and able to provide a bond in an amount satisfactory to the SECC Advisory Committee to protect the participant organizations and donors. (2) SECC Advisory Committee. This ongo-ing committee serves as a central applica-tion point for all charitable organizations applying to participate in the S.E.C.C. SECC . The committee recommends overall policy for the campaign to the Governor, the Statewide Campaign ©i-reotor Chair, and necessary state agencies and recommends the criteria for partici-pation by charitable organizations. The committee reviews the recommendations made by the Statewide Campaign Manag-er and accepts or rejects its recommenda-tions. The committee may, m its discre-tion, require the Statewide Campaign Manager to provide a bond, as provided in Item (l)(e) of this Rule. The commit-tee is composed of 10 state employee members appointed by the Statewide Campaign Director Chair. Members of the committee will initially oervo stag gorod torms of one, two, and three calen dar years determined by the Campaign Director.—As each member's term ex pires,—tfee — replacement—members—wttt serve a three year calendar appointment. Members serve three-year staggered terms at the pleasure of the Statewide Campaign Chair. If a vacancy occurs, the Statewide Campaign Chair shall appoint a replacement to fill the unex-pired term. Any member may be reap-pointed at the end of his or her term. (3) Statewide Campaign Manager. The Statewide Campaign Manager is selected by the Statewide Campaign Chair. The duties of the Statewide Campaign Manag-er include, but are not limited to. the following: (a) serving as the financial administrator of the SECC; (h) determining if the applicant agencies meet the requirements of Rule .0202 of this Chapter; (c) submitting to the Statewide Campaign Chair the name of an organization to serve as Local Campaign Manager; (d) providing the necessary supervision of data processing services in order to process all payroll deduction pledge forms of state employees; (e) receiving reports from the Local Cam-paign Manager; (f) transmitting to each Local Campaign Manager its share of the state employ-ees payroll deduction funds; (g) printing and distributing the pledge form, the campaign report form and collection envelopes to the Local Cam-paign Manager; (h) maintaining an accounting of all funds raised and submitting an interim unau-dited end-of-campaign report of the following: (i) amounts contributed and pledged; (ii) number of contributions; and (iii) amounts distributed to each participat-ing agency; (i) Once applications for acceptance into the campaign have been recommended to the SECC Advisory Committee by the Statewide Campaign Manager, a list of all accepted organizations will be prepared by the Statewide Campaign Manager and distributed to all appli-cants. Serves as the financial administrator for th e Combmed Campaign and as such is responsible for receiving reports from the—leeal — Combined Campaigns,—fer transmitting to each local campaign its share of the state employees payroll deduction funds, and for preparing an end of campaign report which summa rizes all fiscal campaign activity includ ing local audits.—TTie Statewide Cam paign Manager is also responsible for 8:12 NORTH CAROLINA REGISTER September 15, 1993 1009 PROPOSED RULES tbe—printing—and — distribution—of the pledge fonii. campaign report form, and oolleotion envelopes. (4) Local Campaign Chair. Tlie Governor, if asked by the local charitable organiza-tions accepted into the Combined Cam-paign, may appoint an area representative from either state government or the University of North Carolina system to serve as the looal chair Local Chair . This person will be responsible for form-ing a looal—advisory committee Local Advisory Committee for recruitment of volunteer state employeesT^ The Local Chair and the Local Advisory Committee are jointly responsible for the approval of local campaign literature, the establish-ment of local goals as needed, and the distribution of any undesignated funds made available for distribution. (5) Local Campaign Manager. Onoe applioa tions for acceptance into the campaign have boon recommended to th e Commit too by the Statewide Campaign Manager, a list of all accepted organizations will be prepared—by — the Statewide — Campaign Manager and distributed to all applicants. The State Campaign Manager will submit to the State Combined Campaign Director the name of an agency to serve as the local campaign manager. The Campaign Director Chair will approve or reject the State Campaign Manager's recommenda-tion and has the right to name the Local Campaign Manager. The Local Cam-paign Manager must identify itself on all printed materials as the local manager of the SECC rather than of any other orga-nization. (a) For the purpose of selecting a Local Campaign Manager, the Statewide Campaign Chair and Statewide Cam-paign Manager will consider the follow-ing criteria: (i) be a local organization willing to conduct a local SECC; (ii) comply with the terms of the State/Local Managers contract; (iii) have a broad base of community and state employee support and volunteer involvement; (iv) have a demonstrated ability and suc-cessful history of managing fund-raising campaigns that include: (A) development of campaign strate- ID) im IE) development of campaign materi-als; development of volunteer cam-paign structures; training of volunteer solicitors; have a financial structure and resources that can efficiently manage, account for, and disburse funds; be a participant organization of the campaign; must be able to develop financial relationships with a network of statewide organizations so as to ensure the orderly transmittal, disbursement, accounting of, and reporting of donations and pledg-es. fb) The local—manager Local Campaign Manager is responsible for assisting the Local Campaign Chair and Local Cam-paign Advisory Committee in the print-ing and distribution of campaign litera-ture, the collection of pledge reports and envelopes from the state agency volunteers, the development of cam-paign reports, and the forwarding of one copy of each payroll deduction pledge to the Statewide Campaign Manager. In addition, an end of cam-paign report shall be sent to the State-wide Campaign Manager for inclusion in the required fiscal reports. (c) The Local Campaign Manager is re-sponsible for the following: (i) establishing an account with a bank in order to receive deposits of collected funds; and (ii) distributing the funds from the contri-butions in accordance with designa-tions made by state employees. Un-designated funds will be distributed according to APA regulations govern-ing the SECC. Note: A contract between the state and the State-wide Campaign Manager, and the state Statewide and local manager Local Campaign Managers , will be executed in order to develop an acceptable audit trail. The contracts will allow a reasonable charge for campaign expenses to be claimed by the State-wide Campaign Manager and the local manager Local Manager. All terms and conditions of these contracts are subject to review and approval by the Statewide Campaign Director Chair . 1010 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES Statutory Authority G.S. 143-3.3; 143B-10. SECTION .0200 - APPLICATION PROCESS AND SCHEDULE .0201 APPLICATIONS To be eligible to participate in the State Employ-ees Combined Campaign, an organization must apply annually for consideration, either as an independent organization or as a group of organi zations federation . Statutory Authority G.S. 143-3.3; 143B-10. .0202 CONTENT OF APPLICATIONS (a) All organizations seeking inclusion in the campaign must submit an application to the state campaign. The application must include a com-pleted State Employees Combined Campaign Certificate of Compliance, provided by the State-wide Campaign Manager. Included in or attached to the Certificate of Compliance must be: (1) A letter from the board of directors requesting inclusion in the campaign. (2) A complete description of services provided, the service area of the orga-nization, and fund-raising/administrative costs. (3) The most recent audited financial state-ment prepared by a CPA within the past two years. The year end of such audited financial statement must be no earlier than two years prior to the current year's campaign date. The SECC Advisory Committee may grant an exception to this requirement if an organization has filed its Articles of Incorporation with the Secretary of State's Oflice since March i of the preceding year of the current campaign. (4) A board statement of assurance of non-discrimination of employment, board membership and client services. (5) A description of the origin, purpose and structure of the organization. (6) A list of the current members of the board, including their addresses. (7) A letter from the board of directors certifying compliance with the eligibili-ty standards listed in Paragraph (b) of this Rule. (8) When a federated fund-raising organiza-tion submits an application they may submit the credentials of the federation only, not each member agency. By the submission of such, the federations certify that all of their member agencies comply with all the SECC regulations, unless there are exceptions. If there are exceptions to the requirements, the federations must disclose such and explain to the satisfaction of the State-wide Combined Campaign Advisory Committee the reasons for the excep-tion, (b) Organizations must meet the following criteria to be accepted as participants in the Com-bined Campaign: (1) The organization must be licensed to solicit funds in North Carolina if a license is required by law . (2) Have Must provide written proof of tax exempt status for both the IRS federal and N.C. tax purposes. Organizations must certify that contributions from state employees are tax deductible by the donor under N.C. and federal law. (3) Must prepare and make available to the general public an annual audited finan-cial statement. , report or IRS Form 99Gt The SECC Advisory Committee may grant an exception to this require-ment if an organization has filed its Articles of Incorporation with the Sec-retary of State's Office since March \ of the preceding year of the current campaign. An exception to thi s ro quirement is provided for any organiza tion whioh—hoo filed its—Articles of Inoorpomtion—with—the — Secretary—ef State's Offico as of March 1, of the preceding year of the current campaign. (4) If fund-raising and administrative ex-penses are in excess of 25 percent of total revenue, the organization must demonstrate to the satisfaction of the SECC that those expenses for this purpose are reasonable under all the circumstances of the case. (5) Must certify that all publicity and pro-motional activities are truthful and non-deceptive and that all material provided to the SECC is truthful and non-decep-tive . (6) Must agree to maintain the confidential-ity of the contributor list. (7) Must permit no payments of commis-sions, kickbacks, finders fees, percent-ages, bonuses, or overrides for fund; raising, and permit no paid solicitations 8:12 NORTH CAROLINA REGISTER September 15, 1993 1011 PROPOSED RULES of the public. (8) Must have a policy of non-discrimina-tion on the basis of race, color, reli-gion, sex, age, national origin or physi-cal or mental handicap disability for clients of the agency, employees of the agency and members of the governing board. (9) Must provide benefits or services within the local community, meaning that employees in the solicitation area or their femilies should be able to receive benefits or services from the agency within a reasonable distance , or receive benefits—from—voluntary—agonoios . Examples of services are include : (a) (A) research and education in the health and welfare or education fields; (fe) £B} family and child care services; {©) iC) protective services for children and adults; (4) (D) services for children and adults in foster care; ^ £E} services related to the manage-ment and maintenance of the home; {^ £F} day care services for adults and children; (g) (G) transportation services, informa-tion referral and counseling services; (b) (H) the preparation and delivery of meals; (i) £1} adoption services; {j) (J) emergency shelter care and relief services; {k) (K) safety services; (i) £L) neighborhood and community organization services; (ffl) (M) recreation services; (fi) (N) social adjustment and rehabilita-tion services; {e) £0} health support services; or {p) ££} a combination of services de-signed to meet the needs of special groups such as the elderly or handi capped disabled . However, an international organization which provides health and welfere services overseas, whose activities do not require a local presence and which meet other eligibility criteria, may be accepted for participation in the campaign. Statutory Authority G.S. 143-3.3; MSB-10. tOMI .0203 SCHEDULE Complete applications must be submitted to the State Statewide Combined Campaign Advisory Committee by February 15 annually to be included in the fall campaign. Incomplete applications may not be considered by the committee. The Chair will forward all application materials to the State-wide Campaign Manager within three working days after the closing deadline. The Statewide Campaign Manager will report to the Committee its recommendation on each application within three weeks of the closing deadline. The Commit-tee shall affirm or reject each recommendation by the Statewide Campaign Manager and will inform the Statewide Campaign Manager of its decisions. Statutory Authority G.S. 143-3.3; 143B-10. .MQ2 .0204 RESPONSE All applicants will be notified by the Statewide Campaign Manager of the Committee's decision within 50 45 days of the closing deadline. An applicant who is dissatisfied with the determination of its application may file an appeal to the State Advisory Committee within 10 days of the notifi-cation dispatch postmark date. An applicant who is dissatisfied with either the committee's Committee's decision or the appeal determination of the committee Committee may commence a contested case by filing a petition under 150B-23 within 60 days of notification dispatch postmark date of the Committee's decision. Statutory' Authority' G.S 143-3.3; 1438-10. .0303 AH-FORM AND CONTENT OF APPLICATION organizations seeking funding must submit an application to th e state campaign. The application must—include—the — State—Employees—Combined Campaign Certificate of Compliance.—Included in or attached to the Certificate of Compliance must be-w- -A etter—from—the — board—of directors indicating interest. (3) A complete description of services pro vided. and th e s ervice area of th e organi zntion. {54 The most recent audited financial state ment prepared by a CPA.—An exception to this requireme nt is provided for any organization which has filed its Articles of Inoorpomtion with th e Secretary of State's—Office — as of March—]-,—of th e preceding year of the current campaign. f4) A board stateme nt of assurance of non discrimination. 1012 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES ^^ m-f^ A desoription of tho origin, purpooe and Btruoturo of the organization. A list of the current members of the board, including addresses. A letter oortilying compliance with the eligibility standards listed in Rule .0202 of this—Chapter—including—ta* — exempt status, licensing, and showing the per oentage of funds expended in the catego ries of Program and Service, Manage ment and General (Administrative) and Fundmising. Statutory Authority G.S. 143-3.3; 143B-10. SECTION .MOO .0300 - GENERAL PROVISIONS .«401 .0301 OTHER SOLICITATION PROfflBITED Not more than one on-the-job solicitation for funds will be made in any year at any location on behalf of participating SECC agencies. The prohibition does not include Red Cross sponsored Bloodmobiles or employee association solicitations. The State Employee Combined Campaign is the only authorized payroll deduction fund raising effort among state omployoos. Payment may be made by payroll deduction, cash, pledge, or personal check. If an employee chooses to use the payroll deduction method of contributing, he/she must agree to having have the deduction continue for one year with equal amounts being talcen deducted from each check (monthly or biweekly depending on the payroll). All deductions will start with the January payroll and continue through December. If the employee discontinues employment, or actively chooses to discontinue payment, the state will not be responsi-ble for the collection of the unpaid pledge. No deduction will be made for any period in which the employee's net pay, after all legal and previously authorized deductions, is insufficient to cover the allotment. No adjustments will be made in subse-quent periods to make up for deductions missed. Statutory Authority G.S 143-3.3; 143B-10. t0404 .0304 CAMPAIGN LITERATURE Each charitable organization accepted as a part of the campaigUT must provide adequate information about its servicesT including administrative/fund-raising costs, to the local campaign manager Local Campaign Manager for use in the local campaign. Statutory Authority G.S 143-3.3; 143B-10. Statutory Authority G.S 143-3.3; 143B-10. t0403 .0302 COERCIVE ACTIVITIES PROfflBITED (a) In order to insure that donations are made on a voluntary basis, actions that do not allow free choice or that create an impression of required giving are prohibited. Peer solicitation is encour-aged. Employee Employees gifts are kept confi-dentialT^ except that employees may opt to have their designated contributions acknowledged by the recipient organizations. (b) The following activities are not permitted: (1) The Providing providing and using of contributor lists for purposes other than the routine collection^ and forwarding^ and acknowledgement of contributions. (2) TTie establishment of personal dollar goals or quotas. (3) The developing and using of lists of non-contributors. Statutory Authority G.S. 143-3.3; 143B-10. t0403 .0303 PAYMENT METHOD AND TERMS OF CONTRIBUTION t040S .0305 DESIGNATION CAMPAIGN Each employee will be given the opportunity to designate which agency or group of agencies should benefit from his or her contribution to the State Employees Combined Campaign. Each employee will be given a listing list of the ap-proved agencies in the campaign in order to help them make the decision. Statutory Authority G.S. 143-3.3; 143B-10. .0406 .0306 DISTRIBUTION OF UNDESIGNATED FUNDS All contributions made through the S.E.C.C. SECC should be designated to a particular recipi-ent. Any monies not designated to a particular recipient shall be deemed as undesignated funds. Undesignated funds shall be allocated by the S.E.C.C. SECC to the oounty/ local S.E.C.C. SECC committees. The oounty/ local S.E.C.C. SECC shall distribute these funds within their communities. Statutory Authority G.S. 143-3.3; 143B-10. .0407 .0307 EFFECTIVE DATE OF 8:12 NORTH CAROLINA REGISTER September 15, 1993 1013 PROPOSED RULES AMENDED RULES These amended rules shall become offootivo ao gpooified by statute and ohall apply to all applioa tions—then — pending—or thereafter approved be effective for the 1994 SECC and thereafter . Statutory Authority G.S. 143-3.3; 143B-10. TITLE 10 - DEPARTMENT OF HUMAN RESOURCES l\otice is hereby given in accordance with G.S. 150B-21.2 that the Division of Facility Services intends to adopt rules cited as 10 NCAC 3R .0214, .1213- .1219, .1413- .1419,. 1619, .1720. .1912 - .1918. .2120, .2314 - .2320, .2713 - .2719. .3101 -.3108, .3201 - .3207, .3301 -.3306, .3401 - .3407, .3501 - .3507, .3601 - .3607. .3701 - .3707. .3801 - .3807, .3901 - .3908, .4001 - .4012, .4101 - .4107; amend rules cited as 10 NCAC 3R .0304. .0309. .0321, .1613 - .1618, .1713 - .1715. .1717 - .1719, .2113 - .2119; and repeal rules cited as 10 NCAC 3R .1202 - . 1209, . 1402. . 1404 - . 1409, .1716, . 1902, . 1904 - . 1908, .2702- .2707, .2710- .2711. 1 he proposed effective date of this action is January- 4, 1994. 1 he public hearing will be conducted at 10:00 a.m. on October 29, 1993 at the Council Building, Room 201. 701 Barbour Drive, Raleigh, North Carolina 27603. Keason for Proposed Action: 10 NCAC 3R .1202 - .1209, .1213 - .1219, .1617 .1619, .1716, .1720, .2120, 4101 - .4107 - Repeal existing "intensive care service", "open heart surgical services" rules and adopt rules which would incorporate current medical practices and technologies. Amend existing and establish criteria and standards for review of CON applica-tions for Pediatric Intensive Care Services, Cardi-ac Catheterization Services and Ambulatory Sur-gery Services. 10 NCAC 3R .1614, .1615 - .1616, .2115, .2117, .2118 - To adopt as permanent rules amendments to the temporary rules adopted effective September 1 , 1993, which amend existing criteria and stan-dards for Cardiac Catheterization Services and Ambulatory Surgical Services. 10 NCAC 3R .0214, .2314 - .2320, .3101 - .3108, .3201 - .3207, .3301 - .3306, .3401 - .3407, .3501 - .3507, .3601 - .3607, .3701 - .3707, .3801 - .3807, .3901 - .3908, .4001 - .4012 - To adopt as permanent rules the temporary rules adopted effective September 1 , 1993, which amend existing and establishes criteria and standards pursuant to Senate Bill 10 which was ratified on March 18, 1993. 10 NCAC 3R .1402, .1404 - .1409, .1413 - .1419, .1902, .1904 - .1908, .1912 - .1918, .2702 - .2707, .2710 - .2711, .2713 - .2719 - To repeal existing rules and adopt as permanent rules the temporary rules adopted effective September 1, 1993 which establishes criteria and standards pursuant to Senate Bill 10 which was ratified on March 18, 1993. 10 NCAC 3R .0304, .0309, .0321, .1613, .1713 - .1715, .1717 - .1719, .2113 .2114, .2116, .2119 - To adopt as permanent rules the temporary rules adopted September 1, 1993 which amends existing and establishes criteria and standards pursuant to Senate Bill 10 which was ratified on March 18, 1993. i^omment Procedures: All written comments must be submitted to Jackie Sheppard, APA Coordina-tor, Division of Facility Services, P. O. Box 29530. Raleigh, NC 27626-0530. telephone (919) 733-2342, up to and including October 29, 1993. Written comments submitted after the deadline will not be considered. Auditor's Note: Temporary rules have been filed effective September 1, 1993 with the exception of Rules 10 NCAC 3R .1202 - .1209, .1213 - .1219, .1617 - .1619, .1716, .1720, .2120 and .4101 - .4107. The text of the temporary rules may differ from the proposed permanent rules published in this notice. The temporary rules can be obtained by contacting the Office of Administrative Hear-ings, Rules Division at (919) 733-2678. CHAPTER 3 - FACILITY SERVICES SUBCHAPTER 3R - CERTIFICATE OF NEED REGULATIONS SECTION .0200 - EXEMPTIONS .0214 REPLACEMENT EQUIPMENT (a) The purpose of this Rule ]s to define the terms used in the definition of "replacement equipment" set forth in G.S. 131E-176(22a). 1014 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES (h) "Activities essential to acquiring and making operational the replacement equipment" means those activities which are indispensable and requi-site: absent which the replacement equipment could not be acquired or made operational. (c) "Comparable medical equipment" means equipment which is functionally similar and which is used for the same diagnostic or treatment pur-poses. (d) Replacement equipment is comparable to the equipment being replaced if: (1) il has the same basic technology as the equipment currently in use, although it may possess expanded capabilities due to technological improvements; and (2) it is functionally similar and is used for the same diagnostic or treatment pur-poses as the equipment currently in use and is not used to provide a new health service; and (3) the acquisition of the equipment does not result in more than a 10% increase in patient charges or gsr procedure operating expenses within the first twelve months after the replacement equipment is acquired; and (4) it will be located on the same site or campus as the equipment currently in use. (e) Replacement equipment is not comparable to the equipment being replaced ifi (1) the replacement equipment is new or reconditioned, the existing equipment was purchased second-hand, and the replacement equipment is purchased less than three years after the acquisi-tion of the existing equipment; or (2) the replacement equipment is new, the existing equipment was reconditioned when purchased, and the replacement equipment is purchased less than three years after the acquisition of the exist-ing equipment; or (3) the replacement equipment is perma-nently fixed equipment and the existing equipment is one piece of mobile equip-ment which is shared between two or more facilities. (a) After receipt of a letter of intent, the agency shall determine whether the proposed project requires a certificate of need. In molcing this deoiaion the agency shall consider th e obligation of a capital expenditure on behalf of or for a health service faoility to be : (4^ an expenditure to bo obligated or in ourred by the facility'; {3) an expenditure to be obligated or in ourred by any person, board or organi zation having ownership or control of the faoility, or over which tho facility' has ownership or control and which relates to the provision of a hoalth service; 0) an expenditure to bo obligated or in ourred by any person, board or organi zation with which the faoility has a contractual relationship to provide or purchase services, or share spaco, profit or expenses—m—oonnootion—w4tfe—the provision of a health service; or (4) an expenditure to be obligated or in ourred by any person, board or organi zation developing a health service on property owned or leased to or by the faoility. (b) If it is determined that the project requires a certificate of need, the agency will determine the appropriate review category or categories for the proposed project, the type or types of application forms to be submitted, the number of separate applications to be submitted, the applicable review period for each application, and the deadline date for submitting each application. (c) Copies of the application forms may be obtained from the agency. (d) Proposals requiring review will be reviewed according to the categories and schedule set forth in the duly adopted State Medical Facilities Plan in effect at the time scheduled review period com-mences. (e) Applications are competitive if they, in whole or in part, are for the same or similar services and the agency determines that the ap-proval of one or more of the applications may result in the denial of another application reviewed in the same review period. Statutory Authority G.S. 13] £-177(1). Statutory Authority G.S 131E-177; 131E-182. SECTION .0300 - APPLICATION AND REVIEW PROCESS .0304 DETERMINATION OF REVIEW .0309 REVIEW PERIOD (a) The review of an application for a certificate of need shall be completed within 90 days from the beginning date of the review period for the appli- 8:12 NORTH CAROLINA REGISTER September 15, 1993 1015 PROPOSED RULES cation, except as provided in Paragraph (b) of this Rule. (b) Except in the case of an expedited review, Tb« the period for review may be extended for up to 60 days by the agency if it determines that, for one or more of the following reasons, it cannot complete the review within 90 days: (1) the extension is necessary to consider conflicting, contradictory, or otherwise relevant matters; (2) the total number of applications assigned to the project analyst for review, including those in other review periods, preclude the project analyst from completing the review within 90 days; (3) the complexity of the application or applications to be reviewed make it necessary to extend the review period; (4) the review of an applicant's response to the agency's request for additional information has not been completed; (5) the timing of the public hearing which was held for the application or applications under review does not allow sufficient time to consider the information presented; (6) extension of previous reviews necessitated that the project analyst delay the commencement of the review; or (7) the unavailability of the project analyst due to illness, annual leave, litigation associated with other reviews, or other duties and responsibilities. (c) In the case of an expedited review, the review period may be extended only if the Agency has requested additional substantive information from the applicant in accordance with G.S. 131E- 185(c). (d) (e) Applicants will be provided written notice of the extension of the review period after the agency determines that an extension is necessary. Failure to receive such notice prior to the last day of the scheduled review period, however, does not entitle an applicant to a certificate of need nor authorize an applicant to proceed with a project without one. Statutory Authority G.S. 131E-177; 131E-185. .0321 EXPEDITED REVIEW (a) An applicant which desires an expedited review shall submit a petition for an expedited review with the Certificate of Need Section when the application is submitted. (b) The Certificate of Need Section shall review the petition within 15 days from the beginning of the review and shall notify the applicant if the Agency has determined that a public hearing is in the public interest. (c) If the Certificate of Need Section decides that it is not in the public interest to hold a public hearing, a final determination on the request for an expedited review shall not be issued until after the thirty day written comment period has expired. (dj If a request for a public hearing is received by the Agency during the 30 day written comment period, which is defined in G.S. 131E-185, the request for an expedited review shall be denied. (e) After the thirty day written comment period, the Certificate of Need Section shall notify the applicant that its petition for an expedited review is approved or denied. Statutory Authority G.S. 131E-177(1). SECTION .1200 - CRITERIA AND STANDARDS FOR INTENSIVE CARE SERVICES .1202 DEFINITIONS TTie definitions in this Rule will apply to all rules in this Section: W- 4Ifntensive—eere those — services—means sep.'ioes provided by an acute care caro hospital te pati ents who require continuous.—comprehensive — observation and a high level of nursing core. (3) "Intensive care unit" means a separate self suffici ent— e ntity—within—which—aH-necessary supplies and equipment essential—te — provide — inte nsive—eare services afe available—te pati e nts requiring them.—This does not include post op e rativ e r e covery rooms, po s t delivery rooms. ef — emergency observation unita. Statutory Authority G.S 1 31 E- 177(1). .1204 CAPACIT\ IN THE FACILITY AND IN THE HEALTH SERVICE AREA (e^ — Proposals filed by or on behalf of hospital faciliti es—fef — intensive—esfe — services—must—be consistent with the applicable North Carolina State Medical Facilities Plan, with th e applicabl e North Carolina State Health Plan (the one in effect at tifiw of final—age ncy—decision)—aed—with—the applicable h ealth systems plan. 1016 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES {b3 Propooalo—involving—new—ef — expanded intonoivo oare bods must opeoif^' the numbero of intensive oaro boda to bo operated following the oompletion of the proposed project. (e) — A proposal involving additional intensive caro beds shall not be approved unless tho overall as'omgo annual oooupanoy, over the — 12 months immediately—preceding—the — submittal—ef—the proposal, of the total number of funotional existing intensive oaro bods in the facility in which the proposed beds are to bo operated i s at least 70 percent in unite with 20 or more intensive oare bods, 65 percent in units with 10 19 intensive oare bods, and 60 percent in units with 1 9 intensive oare beds. Statutory Authority G.S. 1 31 E- 177(1). .1205 SCOPE OF SERVICES OFFERED A proposal to provide new or expanded intensive care services must document the extent to which tho following will bo available.—If any item will not be available, then substantive information must bo given obviating tho need for that item before approval for a nov'i ' or expanded service can be given: (4^ e — distinct,—identifiable—area—fef—the provision of intensive care services ; (S) twenty four hour on call availability of laboratory and radiology services; {i) 0;/air/suction capability; (4) electronic cardiovascular monitoring capability; (§) capabilities for endotracheal intubation, mechanical—ventilatory—assistance,—asd oardiao pacemalcer insertion; {6) oardiao arrest management plan; f7) twenty four hour blood banlt. Statutory Authority G.S. 131E-177(1). .1206 PROJECTED UTILIZATION/ OCCUPANCY (a)—A proposal to provide new or expanded intensive care services must project an occupancy level for the total intensive care services for each of the first eight calendar quarters following the oompletion of the proposed proj ect. An occupancy level must also bo projected for each specialized type of intensive care service to the extent that specialized types of service are proposed to be operated . —All assumptions, including the opooifio methodologies by which occupancies are projected, must be olearly stated. •(b) A proposal to provide new or expanded intensive care services shall not be approved unless oooupanoy is projected to be at least 75 percent for the total number of intensive care beds proposed to bo operated, no later than three years following the oompletion—ef—the — proposed—project. AH assumptions, including the specific methodologies by which—occupancies—are projected,—must—be olearly stated. (o) A proposal to establish a ne'.'. ' intensive oaro or coronary oare unit shall not be approved unless the utilization of tho unit is projected to be at least at a rate of 4 b>eds at 75 percent occupancy no later than throe years following the oompletion of the proposed project. Statutory Authority G.S. 131E-177(1). .1207 PROJECTED PATIENT ORIGIN (a) — A proposal to provide new or expanded intensive care services must project patient origin by — percentage—by — county—of residence. AH assumptions, including the specific methodology by whioh patient origin is projected, must be clearly stated. (b) A proposal to provide new or expanded intensive care services must show that at least 90 percent of the anticipated patient population is within—45 — minutes—automobile — driving—tiffle (one way) from the facility, with the exception that there — h*^"—be — variance — from—the—90 — percent standard for institutions traditionally offering very specialized levels of intensive oare to a large and geographically diverse population. Statutory Authority G.S. 131E-177(1). .1208 SITE AND EQUIPMENT (a) A proposal to provide new or expanded intensive oare services must provide documentation to shov/ that the services will be offered in a phys ical—environment—that — conforms—te—the requirements of federal, state, and local regulatory bodies . (fe) A proposal to provide new or expanded intensive care services must document the extent to which—th« following,—required—by—th« — Joint Commiss ion on Accreditation of Hos pital s , will be available.—If any item will not be available, then substantive information must be given obviating the need for that item before approval for a new or expanded service can be given: ft) oxygon—and — compressed—air and the means of administration; (3) mechanical ve ntilatory assistance equipment—including airways,—manual 8:12 NORTH CAROLINA REGISTER September 15, 1993 1017 PROPOSED RULES (^ breathing bag and ventilator/reopimtor; oard i QO d e fibrillator with synohronization capability; (43 respiratory—afld — oardiao—monitoring equipment; (5^ thoranoentooio and closed thoroostomy tmohoootomy sot; toumiqucto; f&3 vascular outdovvn oets; (9) infusion pumps; (+0) laryngoscopes and endotracheal tubes; (44^ tracheobronchial—and — gastric—suction equipment; portable x my; patient—weighing—device—fef—bed patients. Statutory Authority G.S. 131 £-177(1). .1209 STAFFEVG (e) A proposal—te — offer new—or expanded intensive care services must provide documentation to show that the appropriate t^'pes and numbers of staff", particularly qualified medical and nursing staff", will be available to support the services. fb) A — proposal—te offer—new—ef— e xpanded intensive care services must provide documentation to show that such services will be coordinated by a registered nurse who—has formal training in intensive care nursing. Statutory Authority G.S 131 £-177(1). .1213 DEFINITIONS The definitions in this Rule shall apply to all rules in this Section: m "Intensive care services" means those £2} services provided by an acute care hospital to patients with a wide variety of illnesses of a life-threatening nature, including patients with highly unstable conditions which require so phisticated medical and surgical intervention and a high level of nursing care and those patients which require continuous, comprehensive observation. "Intensive care unit" means a separate self-sufficient entity which has all supplies, equipment, and staff necessary to offer intensive care services twenty-four hours a day, seven days a week. TTie term does not include post-operative recovery rooms, post-delivery rooms, or emergency observation units. Statutory Authority G.S. 131 £-177(1). .1214 INFORMATION REQUIRED OF APPLICANT (a) Applicant that proposes new or expanded intensive care services shall use the Acute Care Facility/Medical Equipment application form. (b) Applicant proposing new or expanded inten-sive care services shall also submit the following additional information: (1) the number of intensive care beds cur-rently operated by the applicant and the number of intensive care beds to be operated following completion of the proposed project; (2) documentation of the applicant's experi-ence in treating patients at the facility during the past twelve months, includ-ing: (A) the number of inpatient days of care provided to intensive care patients; (B) the number of patients initially treated at the facility and referred to other facilities for intensive care services; and (C) the number of patients initially treated at other facilities and referred to the applicant's facility for intensive care services. (3) the number of patients from the pro-posed service area who are projected to require intensive care services by the patients' county of residence in each of the first 12 quarters of operation, in-cluding all assumptions and methodolo-gies; (4) the projected number of patients to be served and inpatient days of care to be provided by county of residence by specialized type of intensive care for each of the first twelve calendar quar-ters following completion of the pro-posed project, including all assumptions and methodologies; (5) correspondence from the proposed referral sources documenting their intent to refer patients to the applicant's facility; (6) documentation which demonstrates the applicant's capability to communicate effectively with emergency transporta-tion agencies, (7) documentation of written policies and procedures regarding the provision of care within the intensive care unit. 1018 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES which includes, but js riot limited to the following: (A) the admission and discharge of pa-tients: (B) infection control: and (C) safety procedures; (8) documentation that the proposed service shall be operated in an area organized as a physically and functionally distinct entity, separate from the rest of the facility, with controlled access; (9) documentation to show that the services shall be offered in a physical environ-ment that conforms to the requirements of federal, state, and local regulatory bodies: (10) a detailed floor plan of the proposed area drawn to scale: and (1 1) documentation of a means for observa-tion by unit stafF of alj patients ]n the unit from one vantage point. Statutory Authority G.S. 131E-177(1}. .1215 REQUIRED PERFORMANCE STANDARDS The applicant shall demonstrate that the proposed project is capable of meeting the following stan-dards: (1) the overall average annual occupancy rate of all intensive care beds in the facility, excluding neonatal and pediatric intensive care beds, over the 12 months immediate-ly preceding the submittal of the propos-al, shall have been at least 70 percent for facilities with 20 or more intensive care beds, 65 percent for facilities with 10-19 intensive care beds, and 60 percent for facilities with 1-9 intensive care beds; (2) the projected occupancy rate for all inten-sive care beds in the applicant's facility, exclusive of neonatal and pediatric inten-sive care beds, shall be at least 70 per-cent for facilities with 20 or more inten-sive care beds, 65 percent for facilities with 10-19 intensive care beds, and 60 percent for facilities with 1-9 intensive care beds, in the third operating year following the completion of the proposed project; and (3) all assumptions and data supporting the methodology by which the occupancy rates are projected shall be provided. Statutory Authority G.S. 131E-177(1). .1216 REQUIRED SUPPORT SERVICES (a) An applicant proposing new or additional intensive care services shall document the extent to which the following items are available: (1) twenty-four hour on-call laboratory services including microspecimen chem-istry techniques and blood gas determi-nations; (2) twenty-four hour on-call radiology services, including portable radiological equipment; (3) twenty-four hour blood bank services: (4) twenty-four hour on-call pharmacy 15} twenty-four hour on-call coverage by respiratory therapy: oxygen and air and suction capability; electronic cardiovascular monitoring capability: mechanical ventilatory assistance equip-ment including airways, manual breath-ing bag and ventilator/respirator: endotracheal intubation capability: cardiac pacemaker insertion capability; cardiac arrest management plan; patient weighing device for bed patients; and isolation capability, (b) If any item in Subparagraphs (a)(1) - (13) of this Rule will not be available, the applicant shall document the reason why the item is not needed (61 m 18} 19} (10) ILQ (12) (13) for the provision of the proposed services. Statutory Authority G.S. 131E-177(1). .1217 REQUIRED STAFFING AND STAFF TRAINING The applicant shall demonstrate the ability to meet the following staffing requirements, in accordance with recommendations and standards from the Society of Critical Care Medicine for intensive care units: (1) nursing care shall be supervised by a qualified registered nurse with specialized training in the care of critically ill patients, cardiovascular monitoring, and life support; (2) direction of the unit shall be provided by a physician with training, experience and expertise in critical care; £3} assurance from the medical staff" that twenty-four hour medical and surgical on-call coverage is available: and (4) appropriate inservice training or continuing education programs shall be 8.12 NORTH CAROLINA REGISTER September 15, 1993 1019 PROPOSED RULES provided for the intensive care staff. Statutory Authority G.S. 131 £-177(1). .1218 ACCESSIBILITY (a) The applicant shall provide documentation describing the mechanism that will be used to insure that the projected number of medically underserved will be served in the facility. (b) The applicant shall provide written admissions policies identifying any prepayment or deposit requirements for the facility and specifically stating the admission requirements for patients in each of the following payor categories: (1) Medicare; (2) Medicaid; (3) Blue Cross and Blue Shield; (4) Commercial Insurance; (5) State Employees Health Plan; (6) Self-Pay (includes self-pay, indigent and charity care); and (7) Other as identified by the applicant. (c) The applicant shall provide a written description of the billing procedures, including the credit and collection policies that will be utilized by the facility. (d) The applicant shall document that the health care community in the service area, including the Departments of Social Services and Health, have been invited to comment on the proposed project, particularly with regard to the facility's referral mechanisms and admissions policies for the medically underserved. Statutory Authority G.S 131E-177(1). .1219 DATA REPORTING REQUIREMENTS The facility shall agree to provide, upon the request of the Division of Facility Services, the following types of data and information, in accordance with data format and reporting requirements formulated by the Division of Facility Services: (1) demographic data on patients treated; (2) financial data; and (3) clinical data. Statutory Authority G.S. 131 £-177(1). SECTION .1400 - CRITERIA AND STANDARDS FOR NEONATAL SERVICES .1402 DEFINITIONS The definitions in this Rule will apply to all rules in this Section: (4^ "Normal newborn ocrvicoo" mcano those routine Bervioes—provided by an acute oare hospital to—normal fiill term -asd normal pre term infante weighing at loost 2000 grams at birth. Routine oaro within th+fi context includes increased observation, screening, and otabilization e# — infants—within—tbe—fi«t — ieuf—te twenty four hours following birth. "Neonatal—continuing—eaf=e (3)- services" m-means— those—services—provided—by—aa acute care hospital to low birth weight infants who are not sick but who require frequent feeding, infants who no longer require neonatal intermediate eare services—fetrt—wbe—stiH — require more nursing hours than normal infants, and infants who require close obsop>'ation for any reason. "Neonatal—intermediate—eafe — s ervices" means those services—provided by an acute care hospital to siok infants who do not require neonatal intensive care but who do—require six to twelve nursing hours per day. "Neonatal intensive care services" means those services provided by an acute care hospital—te — severely—iH — infants—wbe require constant nursing care, as well as continuous cardiopulmonary and other supportive care.—Neonatal intensive care difFers from neonatal intermediate care with — regard—te—the — complexity'—&e multiplicity' of patient problems, e.g. care required for neonatal surgery' patients. "Neonatal services"—means any of the services defined in this Rule. {4^ {§)- Statutory Authority G. S 131E-1 77(1). .1404 CAPACITY E^J THE FACILITY AND ESf THE HEALTH SERVICE AREA 4a) — Proposals filed by or on behalf of hospital facilities for neonatal services must be consiste nt with the applicable North Carolina State Medical Facilities Plan, with th e applicable North Carolina State Health Plan (the one in effect at time of final agency decision), and with the applicable health systems plan. {b) Proposals—involving—new er— e xpanded neonatal bassinets/beds must specify' the numbers of neonatal bassinets/beds to be operated following the completion of the proposed proj ect. Such specification must be in terms of normal newborn services.—neonatal—continuing—eafe — services. 1020 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES neonatal intermodiate ooro oorvioes, and neonatal intonoivo oaro oorvioes. If lovela of oare other than tbat—fep — normal—newborns—afe — involved,—tbe proponont must define tho manner in whioh the proponent deoignatoo beds for auoh lovelo. •(e) — A proposal involving a net inoreose in the tetal number—of a—faoility's—existing—neonatal intermediate oare beds and neonatal intensive oare beds shall not be approved unless the overall average annual oooupanoy,—over the — 12 months immediately—preceding—the — submittal—ef—the proposal,—ef—th« — functional—existing—neonatal intermediate care beds in the facility in whioh the proposed beds are to bo operated is at least 8 percent. 4d) He—proposal—fer — additional—neonatal intermediate care or neonatal intensive care beds shall be approved unless it is determined that an unmet need exists in the health service area or in the proponent's defined service area in whioh the proposed beds are to be operated. Need for neonatal—intermediate—eare—beds—asd — neonatal intensive care beds shall be computed for each of the six established health service areas in North Carolina by: (4-) identifying the annual number of live births occurring at all hospitals located within the health service area, using the latest available data compiled by the Division of Health Services; (3) identifying th e low birth weight rate (percent—of live—births—below—2500 grams) for the births identified in (1) of tbis — Subparagraph,—using—the — latest available data compil ed by the Division of Health Services; f^ dividing—the—lew—bifth — weight—Fate identified in (2) of this Subparagraph by .08 and subsequently multiplying the resulting quotient by four; and {4) determining need for neonatal intensive ©are—beds—aed — neonatal—intermediate oare beds in the h ealth service area as the product of: (A) — the product derived in—(3) of this m- Subparagraph, and -the — quotient—resulting from—the division of the number of live births in the initial year of the projection identified in (1) of this Subparagraph by the number 1000. Statutory Authority G.S. 131E-177(1). .1405 SCOPE OF SERVICES OFFERED {a) — A proposal to provide new normal newborn services or neonatal continuing care services must document the extent to which the following Vr'ill be available.—If any item will not be available, then substantive information must be given obviating tho need for that item before appro^'al for a new or expanded service can be given: <4^ a distinct,—identifiable—area — for tho provision of the proposed service; 43) competence to manage uncomplicated labor—asd — delivery—ef — normal—term newborn; 4^) capability fef continuous fetal monitoring; (4) a — continuing— e ducation—program—ee resuscitation—te — enhance—competence among all delivery room personnel in tb« immediate evaluation aft4 resuscitation of the newborn and of tho mother; (#) availability of obstetric services; {6) capability for cesarean section within 30 minutes at any hour; and f?) twenty four hour on call availability of blood,—anesthesia—service,—radiology service, clinical laboratory service. (b) — A proposal to provide new or expanded neonatal intermediate care services or neonatal intensive care services must meet the requirements of (a) of this Rule as well as document the extent to whioh the following will be available.—If any itofH—wiH—net—be — available,—then— s ubstantive information must be given obviating the need for that item before approval for a new or expanded service can be given: -a k^ distinct,—identifiable—area—for—the provision of th e proposed sorvioo; {3) competence—te — manage — labor—and delivery of premature newborns and newborns with complications; {5) twenty four hour coverage »f microchemistry hematology and blood gases; f4) twenty four hour coverage by respiratory therapy; {5) twenty four hour coverage with portable radiographic capability; -Q;/air/suction capability'; 6^ e lectronic cardiovascular ft»d respiration monitoring capability; 48)- capabilities for endotracheal intubation and meohanical ventilator^' assistance ; oardio respirator^'—arrest—management plan. 8:12 NORTH CAROLINA REGISTER September 15, 1993 1021 PROPOSED RULES Statutory Authority G.S. 131E-177(1). .1406 PROJECTED UTILIZATION/ OCCUPANCY (a) ProponentB proposing new normal newborn and neonatal continuing oare oervioes must per form, or projeot to perform, at looot 500 deliver ioo, per year except that a varianoo from this standard will be allowed to the extent that a sub stantial portion of the population to be served reside more than 45 minutes automobile driving time (one vipy) from existing inpatient noonatol servioeo. {b) A proposal to provide new normal newborn or neonatal continuing oare oervioes. or new or expanded interm ediate care oervioes or neonatal intensive oare services , or any combination of the four muot projeot an ocoupanoy level for each of the services for each of the first eight calendar quartero following the completion of the propooed projeot.—All assumptions, including the speoifio methodologies by whioh oooupancies are projected, must be clearly stated. {&)—A proposal to provide new normal newborn and neonatal continuing care oervioes shall not be approved—unless—for the total—number of beds proposed to—be operated annual—occupancy—ts projected to be 50 percent. Occupancy i o proj ected to be 60 percent for a 1 10 bed unit, 65 percent for a 11 20 bed unit. 70 percent for a 21 30 bed unit, and 75 percent for a unit of 31 beds or more after two years foUowmg the completion of the proposed project.—All assumptions, including the speoifio methodologies by whioh occupancies are projected, must be clearly stated. fd) — A proposal to provide new neonatal inter mediate care services or new neonatal intensive care services shall not be approved unless ocou panoy is projected to be at least 75 percent for the total number of neonatal intermediate care beds and neonatal intensive oare beds proposed to be operated, no later than three years following th e completion of the propo sed projects.—All assump tions,—mcluding—the specific—methodologi es—by which occupancies are projected, must be clearly stated . Statutory Authority G.S 131 E-1 77(1). service by poroontage by oounty of residonoo.—AH assumptions, including the speoifio methodology by which patient origin is projootod.—must be olearly stated. {b) — A proposal to provide now normal newborn or neonatal continuing care services must doou ment that at least 90 percent of the anticipated patient population is within 45 minutes driving time (one way) from th e facility. (e) — A proposal to provide now or expanded neonatal—intermediate oare sorvioos—or new or expanded neonatal—intensive care servicoo—mus t document that at least 90 percent of tho anticipated patient population is within 90 minutes driving time (one v.oy) from the facility', with tho oxcop tion that there may be a variance from the 90 percent standard for institutions with very special ized levels of neonatal care to a largo and goo graphically diverse population. Statutory Authority G.S 131E-1 77(1). .1408 SITE AND EQUIPMENT A proposal to provide new or expanded neonatal services must provide documentation to show that the services will be ofiFered in a physical environ ment that conforms to the requirement!) of federal, state, and local regulator^' bodies. Statutory Authority G.S 131E-177(1). .1409 STAFFING (a) A proposal to offer new or expanded ncona tal services must provide documentation to show that the appropriate types and numbers of staff, particularly qualified medical and nursing staff", will be available to support the servicoo. {b)—A proposal to off^er new or expanded neona tal intermediate care or neonatal intensive care services must provide documentation to show that such services will: ^4^ be coordinated by a registered nurse who has completed an organized eduoa tional program in neonatal intermediate and intens ive care, and (3) be under the direction of a physician with training and experience in neonatal intermediate and intensive care. .1407 PROJECTED PATIENT ORIGIN (a) — A proposal to provide new normal newborn or neonatal continuing care services, or new or expanded intermediate care services or neonatal intensive care services, or any combination of th e four must project patient origin for each proposed Statutory Authority G.S 131 E-1 77(1). .1413 DEFINITIONS The definitions in this Rule shall apply to all rules in this Section: ( 1) "Approved neonatal service" means a 1022 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES I2i i21 14} 15} neonatal service that was not operational prior to the beginning of the review period but that had been issued a certificate of need or for which development had been initiated prior to March 18. 1993 in accordance with G.S. 131E-175. et. al. "Existing neonatal service" means a 16} neonatal service in operation prior to the beginning of the review period. "High-risk obstetric patients" means those patients requiring specialized services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery. The services are characterized by specialized facilities and staff for the intensive care and management of high-risk maternal and fetal patients before and during delivery. "Level I neonatal service" means those routine services provided by an acute care hospital to normal full -term and pre-term infants weighing at least 2000 grams at birth. Level I neonatal services include the observation, screening, and stabilization of: infants following birth who are served in a bassinet; infants who are not sick but who require special care and frequent feedings; infants who no longer require Level II or Level III neonatal services, but who still require more nursing hours than normal infants; and infants who require close observation in a licensed acute care bed. "Level II neonatal service" means the performance of Level I neonatal services, plus the management of high-risk, small, and sick neonates with a moderate degree of illness that are admitted within the hospital or transferred from another facility. Level II neonatal services involve the management of newborns weighing between approximately 1,500- 2,500 grams (or approximately 32 and less than 36 completed weeks of gestational age) that are relatively healthy, or involve intermediate care services for sick infants who do not require intensive care but who do require six to twelve nursing hours per day. Level II neonatal services are provided in a licensed acute care bed. "Level III neonatal service" means the performance of Level I and Level U m £8} £9} (10) neonatal services plus the management of high-risk newborns weighing less than 1,500 grams (or approximately under 32 weeks of gestational age), which requires neonatal expertise. Level III neonates require constant nursing care, including but not limited to continuous cardiopulmonary and other supportive care, care required for neonatal surgery patients and other intensive care services. Level III neonatal services are provided in a licensed acute care bed. "Neonatal intensive care services" is defined in G.S. I31E-I76(15b). "Neonatal service area" means a geographic area defined by the applicant from which the patients to be admitted to the service will originate. "Neonatal services" means any of the Level L Level II or Level III services defined in this Rule. "Obstetric services" means any normal or high-risk services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery. "Perinatal services" means services provided during the period shortly before and after birth. "Perinatal regions" mean a geographic area of the state as established by the Perinatal Council. A copy of the perinatal regions may be obtained from the Division of Maternal and Child Health, Department of Environment, Health and Natural Resources, 1330 St. Mary's Street, Raleigh. NC. 27605-3248. Statutory Authority G.S. 131E-177(1). .1414 INFORMATION REQUIRED OF APPLICANT (a) An applicant proposing to develop a new neonatal service or to add a bed to an existing neonatal service shall use the Acute Care Facility/Medical Equipment application form. (b) The applicant shall provide the following additional information: (1 ) the current number of Level I bassinets. Level I beds. Level H beds and Level III beds operated by the applicant; (2) the proposed number of Level I bassinets. Level I beds. Level H beds and Level III beds to be operated following completion of the proposed nil 12} 8:12 NORTH CAROLINA REGISTER September 15, 1993 1023 PROPOSED RULES project; (3) evidence of the applicant's experience in treating the following patients at the facility during the past twelve months, including: (A) the number of obstetrical patients treated at the acute care facility; (B) the number of neonatal patients treated in Level I bassinets. Level I beds. Level II beds and Level III beds, respectively; (C) the number of inpatient days at the facility provided to obstetrical patients; (D) the number of inpatient days provided in Level I beds. Level U beds and Level III beds, respectively; (E) the number of high-nsk obstetrical patients treated at the applicant's facility and the number of high-risk obstetrical patients referred from the applicant's facility to other facilities or programs; and (F) the number of neonatal patients referred to other facilities for services, identified by required level of neonatal service (i.e. Level ]_, Level II or Level III); (4) the projected number of neonatal patients to be served identified by Level L Level II and Level III neonatal services and by county of residence for each of the first twelve quarters of operation following the completion of the project, including the methodology and assumptions used for the projections; (5) the projected utilization of the Level I bassinets. Level I beds. Level H beds and Level III beds, respectively, by county of residence for each of the first twelve quarters of operation following completion of the project, including the methodology and assumptions used for the projections; (6) if proposing to provide Level I neonatal services, documentation that at least 90 percent of the anticipated patient population is within 45 minutes driving time one-way from the facility; (7) if proposing to provide Level ] neonatal services, documentation of a written plan to transport infants to Level II or Level III neonatal services as the infant's care re<quires; 181 19} (10) an 12) if proposing to provide Level U or Level III neonatal services, documentation that at least 90 percent of the anticipated patient population is within 90 minutes driving time one-way from the facility, with the exception that there shall be a variance from the 90 percent standard for facilities which demonstrate that they provide very specialized levels of neonatal care to a large and geographically diverse population, or facilities which demonstrate the availability of air ambulance services for neonatal patients; evidence that existing and approved neonatal services and obstetric services in the applicant's perinatal region and in the applicant's defined neonatal service area are unable to accommodate the applicant's projected need additional Level I] and Level services; for III IB) IQ ID] ID IF] (13) documentation of the availability of existing obstetric services, and the identification of ajj obstetrics programs and neonatal services which currently serve patients from the applicant's primary service area; an analysis of the proposal's impact upon existing and approved neonatal services in the same perinatal region(s) and those perinatal regions adjacent to the perinatal region(s) in which the applicant proposes to provide services, including but not limited to the proposal's effect on the utilization of existing neonatal services, except when an applicant demonstrates that they provide very specialized levels of neonatal care to a large and geographically diverse population; evidence that the applicant shall have access to a transport service with at least the following components: trained personnel; transport incubator; emergency resuscitation equipment; oxygen supply and the means of administration; portable cardiac and temperature monitors; and a ventilator; documentation that the new or additional neonatal service shall be 1024 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES iM £B} im £F} (14) coordinated with the existing statewide perinatal network, including but not limited to: the Division of Maternal and Child Health of the Department of Environment, Health and Natural Resources, the physicians' statewide neonatal bed locator system, existing neonatal services, existing obstetrical services, home health care agencies, other hospitals, and local Departments of Social Services; copies of written policies which provide for parental participation in the care of their infant, as the infant's condition family care (15) permits, in order to facilitate adjustment and continuity of following discharge: and copies of written policies and £A} Hi ID} {c} An additional following: m oi m 141 (51 procedures regarding the scope and provision of care within the neonatal service, including but not limited to the following: the admission and discharge of patients; infection control; pertinent safety practices; and the triaging of patients requiring consultations, including the transfer of patients to another facility, applicant proposing to provide new or neonatal services shall provide the documentation that the proposed service shall be operated in an area organized as a physically and functionally distinct entity with controlled access; documentation to show that the new or additional Level I^ Level II or Level III neonatal services shall be offered in a physical environment that conforms to the requirements of federal , state, and local regulatory bodies; a detailed floor plan of the proposed area drawn to scale; documentation of direct or indirect visual observation by unit staff of all patients from one or more vantage points; and documentation that the floor space allocated to each bed and bassinet shall accommodate equipment and personnel to meet anticipated contingencies. Statutory Authority G.S. ] 31 E- 177(1). .1415 REQUIRED PERFORMANCE STANDARDS (a) An applicant shall demonstrate that the proposed project is capable of meeting the following standards: (1) applicants proposing new or additional Level I services shall perform or project to perform, at least 500 deliveries per year, except that a variance from this stendard shall be allowed to the extent that a major portion of the population to be served reside more than 45 minutes automobile driving time one-way from existing inpatient neonatal services; (2) applicants proposing new or additional Level I services shall demonstrate that the following standards will be met: (A) the occupancy of the applicant's tofal number of neonatal beds is projected to be 50% or more during the first year of operation following completion of the proposed project- Provide all assumptions and data supporting the methodology used for the projections; (B) if an applicant is proposing additional Level I services and does not currently provide Level II or Level III services, the projected occupancy of the proposed service shall be at least 75% after the second year of operation following completion of the proposed project and provide all assumptions and data supporting the methodology used for the projections; (C) if an applicant is proposing additional Level I services and currently provides Level II or Level III services, the projected occupancy of all neonatal services in the facility shall be at least 65% after the second year of operation following completion of the proposed project, and provide all assumptions and data supporting the methodology used for the projections; the total number of Level I neonatal bassinets and Level I neonatal beds projected to be operated in the facility shall exceed the number of obstetric beds in the facility by at least 25%; and £D} 8:12 NORTH CAROLINA REGISTER September 15, 1993 1025 PROPOSED RULES lEi ill (4) the total number of Level I neonatal bassinets and Level I neonatal beds projected to be operated in the facility shall exceed the number of obstetric beds in the facility by at least 35% if Level n or Level 111 services will be provided in the facility; if an applicant proposes an increase in the number of the facility's existing Level II or Level III beds, the overall average annual occupancy of the total number of existing Level II and Level III beds in the facility is at least 75%. over the \2 months immediately preceding the submitfal of the proposal; and if an applicant is proposing to develop a new or additional Level II or Level III beds, the projected occupancy of the total number of Level II and Level III beds proposed to be operated after the second year of operation of the proposed project shall be at least 75%. The applicant shall document the assumptions and provide data supporting the methodology used for the projections. (b) If an applicant proposes to develop a new Level II or Level III service the applicant shall document that an unmet need exists in the perinatal region or in the applicant's defined neonatal service area. The need for Level II and Level III beds shall be computed for each of the perinatal regions in North Carolina or in the applicant's neonatal service area by: (1) identifying the annual number of live births occurring at all. hospitals within the perinatal region or proposed neonatal service area, using the latest available data compiled by the State Center for Health and Environmental Statistics; (2) identifying the low birth weight rate (percent of live births below 2.500 grams) for the births identified in £1J of this Paragraph. using the latest available date compiled by the State Center for Health and Environmental Statistics; (3) dividing the low birth weight rate identified in (2) of this Paragraph by 08 and subsequently multiplying the resulting quotient by four; and (4) determining the need for Level II and Level III beds m the perinatal region or proposed neonatal service area as the product of: (A) the product derived in £3) of this Paragraph, and (B) the quotient resulting from the division of the number of live births in the initial year of the determination identified in OJ of this Paragraph by the number 1000. Statutory Authority G.S. 131E-177(1). .1416 REQUIRED SUPPORT SERVICES (a) An applicant proposing to provide new or additional Level f. Level II or Level III services shall document that the following items shall be available, unless an item shall not be available, then documentation shall be provided obviating the need for that item: m 121 ID competence to manage uncomplicated labor and delivery of normal term newborn; capability for continuous fetal monitoring; a continuing education program on resuscitation to enhance competence among all delivery room personnel in the immediate evaluation and resuscitation of the newborn and of the mother; obstetric services; anesthesia services; capability of cesarean section within 30 minutes at any hour of the day; and twenty-four hour on-call blood bank, radiology, and clinical laboratory services. (b) An applicant proposing to provide new or additional Level II or Level III services shall document that the following items shall be available, unless any item shall not be available, then documentation shall be provided obviating the need for that item: labor £41 (5) (6) ill 12} £3} 14] 15} £6} competence to manage and delivery of premature newborns and newborns with complications; twenty-four hour availability of microchemistry hematology and blood gases; twenty-four hour coverage by respiratory therapy; twenty-four hour radiology coverage with portable radiographic capability; oxygen and air and suction capability; electronic cardiovascular and 1026 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES respiration monitoring capability; (7) vital sign monitoring equipment which has an alarm system that is operative at all times; (8) capabilities for endotracheal intubation and mechanical ventilatory assistance; £9} cardio-respiratory arrest management plan; (10) isolation capabilities; (11) social services staff; (12) occupational or physical therapies with neonatal expertise; and (13) a registered dietician or nutritionist with training to meet the special needs of neonates. (c) An applicant proposing to provide new or additional Level III services shall document that the following items shall be available, unless any item shall not be available, then documentation shall be provided obviating the need for that item: (1) pediatric surgery services; ophthalmology services; pediatric neurology services; pediatric cardiology services; on-site laboratory facilities; computed tomography and pediatric cardiac catheterization services; emergency diagnostic studies available 24 hours per day; designated social services staff; and serve as a resource center for the 13} £41 15} £6} 01 (81 19} statewide perinatal network. Statutory Authority G.S. 131E-177(1). .1417 REQUIRED STAFFING AND STAFF TRAINING An applicant shall demonstrate that the following staffing requirements for hospital care of newborn infants shall be met: (1) If proposing to provide new or additional Level I services the applicant shall provide documentation to demonstrate that: (a) the nursing care shall be supervised by a registered nurse in charge of perinatal facilities; (b) a physician is designated to be responsi-ble for neonatal care; and (c) the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis. (2) If proposing to provide new or additional Level II services the applicant shall pro-vide documentation to demonstrate that: (a) the nursing care shall be supervised by a registered nurse with educational preparation and advanced skills for maternal-fetal and neonatal services; (b) the service shall be stafFed by a board certified pediatrician with certification, special interest, experience, or training in neonatology; and (c) the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis. (3) If proposing to provide new or additional Level III services the applicant shall provide documentation to demonstrate that: (a) the nursing care shall be supervised by a registered nurse with educational preparation and advanced skills for maternal-fetal and neonatal services; (b) the service shall be staffed by a full-time board certified pediatrician with certification in neonatal medicine; and (c) the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis. (4) All applicants shall submit documentation which demonstrates the availability of appropriate inservice training or continu-ing education programs for neonatal staff. (5) All applicants shall submit documentation which demonstrates the proficiency and ability of the nursing staff in teaching parents how to care for neonatal patients following discharge to home. (6) All applicants shall submit documentation to show that the proposed neonatal ser-vices will be provided fn conformance with the requirements of federal . state and local regulatory bodies. Statutory Authority G.S. 131E-]77(1). .1418 DATA REPORTING REQUIREMENTS The facility shall agree to provide, upon the request of the Division of Facility Services, the following types of data and information, m accor-dance with data format and reporting requirements formulated by the Division of Facility Services: (1) demographic data on patients treated; (2) financial data; and (3) clinical data. Statutory Authority G.S 131E-177(1). .1419 ACCESSIBILITY 8:12 NORTH CAROLINA REGISTER September 15, 1993 1027 PROPOSED RULES (a) The applicant shall provide documentation describing the mechanism that shall be used to insure that the projected number of medically underserved shall be served in the unit. (b) The applicant shall provide a copy of the written admissions policies identifying any prepay-ment or deposit requirements for the facility and stating the admissions requirements for each of the following payor categories: m 121 £3} 14] 15) (6} Medicare; Medicaid; Blue Cross and Blue Shield; Commercial Insurance; indigent 17} State Employees Health Plan; Self-Pay (includes self-pay, and charity care) ; and Other as identified by the applicant. (c) The applicant shall provide a written descrip-tion of the billing procedures, including the credit collection policies, that shall be utilized by the facility. (d) The applicant shall document that the health care community in the applicants neonatal service area, including the Departments of Social Services and Health, have been invited to comment on the proposed project, particularly with regard to the facility's referral mechanisms and admissions policies for the medically underserved. Statutory Authority G.S. 1 31 E- 1 77(1). SECTION .1600 - CRITERIA AND STANDARDS FOR CARDIAC CATHETERIZATION EQUIPMENT AND CARDIAC ANGIOPLASTY EQUIPMENT .1613 DEFINITIONS The following definitions wiH shall apply to all rules in this Section: (1) "Approved" means the equipment was not in operation prior to the beginning of the review period and had been issued a certificate of need or had been acquired prior to March 18, 1993 in accordance with G.S.I3IE-175, et. al. (2) fB "Capacity" of a an item of cardiac catheterization room equipment or cardi-ac angioplasty equipment is considered to be lOOQ means 1270 diagnostic-equiva-lent procedures per year. One PTCA therapeutic cardiac catheterization proce-dure is valued at twe 1 .67 diagnostic-equivalent procedures. One pediatric cardiac catheterization procedure per-formed on a patient age five or under is valued at two diagnostic-equivalent pro-cedures. All other procedures are valued at one diagnostic-equivalent procedure. (3) "Cardiac angioplasty equipment" is de-fined in G.S.131E-176(2e). (4) (3) "Cardiac catheterization" is means a diagnostic, electrophysiology or therapeu-tic procedure performed using cardiac catheterization equipment or cardiac angioplasty equipment in a cardiac cathe-terization room, whereby a flexible tube is inserted into the patient's body , usually through an extremity blood veoael, and advanced under—fluorosoopio—guidance into the heart chambers to perform a hemodynamic or angiographic examina-tion or therapeutic intervention of the left and or right heart chamber, or coronary arteries-; — therapeutic—intervention—m— a coronary artery' may also be performed using oardiao catheterization. By thi s definition a cardiac catheterization procc dure does not include a simpl e right heart catheterization for monitoring purposes as might bo done in an electrophysiology laboratory, pulmonary angiography as an isolated—procedure,—&f—cardiac—pacing through a right e l ectrode catheter. k does include angiographic procedures to evaluate the coronary' arteries, and aortic root injections to examine the degree of aortic regurgitation or deformity of aortic valve . (5) "Cardiac catheterization equipment" is defined in G.S. 131E-176(2f). (6) (^ "Cardiac catheterization procedure" means a single episode of diagnostic, electrophysiology or therapeutic catheter-ization which occurs during one visit to a cardiac catheterization room. (7) (4) "Cardiac catheterization room" means a room in a hospital or a mobile unit in which has the there is cardiac catheteriza-tion or cardiac angioplasty equipment required—te — perform—angiographic—and phys iologic for the provision of cardiac catheterization procedures , and which has been approved by th e Certificate of Need Section as a cardiac catheterization room services . (8) fl-B " Cardiac catheterization Sservice area" means a geographical area defined by the proponent applicant , which has boundaries that are not farther than 90 road miles from the facility, if the facility 1028 8:12 NORTH CAROLINA REGISTER September 15. 1993 PROPOSED RULES has a comprehensive cardiac services program; and not farther than 45 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures. £9} "Cardiac catheterization services" means the provision of diagnostic cardiac catheterization procedures, therapeutic cardiac catheterization procedures or electrophvsiology catheterization procedures. (10) {§) "Comprehensive cardiac services program" means a cardiac services program which provides the full range of clinical services associated with the treatment of cardiovascular disease including community outreach, emergency treatment of cardiovascular illnesses, non-invasive diagnostic imaging modalities, diagnostic and interventional therapeutic cardiac catheterization procedures , open heart surgery and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services menf shall be provided by the applicant or through arrangements with other agencies and fecilities located in the same city. All other components of a comprehensive cardiac services program must shall be provided within a single facility. (11) (6) "Diagnostic cardiac catheterization procedure" means a cardiac catheterization procedure performed using cardiac catheterization or cardiac angioplasty equipment for the purpose of detecting and identifying defects or diseases in the great arteries or veins of the heart, or abnormalities in the heart structure. f^ "Expanded cardiac cath eterization service " means the addition or conversion of a room to be dedicated to oardiao catheterization procedures; ef the purchase ef additional equipment specially—designed—te — perform—cardiac catheterizations. (12) " Elect rophysio logy catheterization procedure" means a diagnostic or therapeutic cardiac catheterization procedure performed to study the electrical conduction activity of the heart and characterization of atrial ventricular arrhythmias utilizing cardiac catheterization equipment or cardiac (13) (14) (15) {«^ (16) (17) (18) angioplasty equipment. "Existing" means the equipment was in operation prior to the beginning of the review period. "High-risk patient" means a person with reduced life expectancy because of left main or multi-vessel coronary artery disease, often with impaired left ventricular function and with other characteristics as American referenced in o 1 1 e g e the oj Cardiology/American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories (1991) report. "Mobile equipment" means cardiac angioplasty equipment catheterization or cardiac equipment and transporting equipment which is moved to provide services at two or more host facilities. "Pediatric cardiac catheterization procedure" mean s a cardiac catheterization procedure performed on a patient age five or under. (9) "Percutaneous transluminal coronary angioplasty (PTCA)" is a interventional one type of therapeutic cardiac catheterization procedure used to treat coronary artery disease in which a balloon-tipped catheter is placed in the diseased artery and then inflated to compress the plaque blocking the artery. {40) "Primary cardiac catheterization service area" means a geographical area defined by the proponent applicant . which has boundaries that are not farther than 45 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 23 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures. "Therapeutic cardiac catheterization procedure" means a cardiac catheterization procedure performed for the purpose of treating or resolving certain anatomical or physiological conditions which have been determined to exist in the heart or great arteries or veins of the heart. Statutory Authority G.S. 1 31 E- 177(1). .1614 INFORMATION REQUIRED OF 8:12 NORTH CAROLINA REGISTER September 15, 1993 1029 PROPOSED RULES APPLICANT (a) An applicant that proposes a — sew—ef expanded cardiac catheterization service to acquire cardiac catheterization or cardiac angioplasty equipment must provide the information requested eft shall use the acute care facility/medical equipment application form. (b) In addition to information requested on the aouto care application form, th e The applicant must shall provide the following additional information based on the population residing within the applicant's proposed cardiac catheterization service area : (1) the projected number of cardiac catheterization procedures, by CPT or ICD-9-CM by ty^ classification of cardiac catheterization procedure^ to be completed performed in each cardiac catheterization room for each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections; (2) documentation of the applicant's experience in treating cardiovascular patients at the facility during the past twelve months, including; (A) the number of patients receiving stress tests; (B) the number of patients receiving intravenous thrombylitio thrombolytic therapies; (C) the number of patients presenting in the Emergency Room or admitted to the hospital with suspected or diagnosed acute myocardial inferction; and (D) the number of patients referred to other facilities for cardiac catheterization procedures and/or or open heart surgery procedures, by type of procedure; (3) the number of patients from the proposed service area who are projected to receive cardiac catheterization services by patient's county of residence in each of the first 12 quarters of operation, including the methodology and assumptions used for these projections; (4) the number of patients from the proposed primary service area who are projected to receive cardiac catheterization services by patient's county of residence in each of the first 12 quarters of operation, including the methodology and assumptions used for these projections; (5) documentation of the applicant's projected referral sources of patient* referrals that are located in the proposed service area, including letters from the referral sources that demonstrate their intent to refer patients to the applicant for cardiac catheterization services ; (6) evidence of the applicant's capability to communicate e fficiently with emergency transportation agencies and with an established comprehensive cardiac services program; (7) the number and composition of cardiac catheterization teams available to the applicant; (8) a brief description of documentation of the applicant's in-service training or continuing education programs for cardiac catheterization team members; (9) a written agreement with a comprehensive cardiac services program specifying that specifies the arrangements for referral and transfer of patients seen by the proponent applicant which and that includes a process to alleviates the need for duplication in catheterization studies; ( 10) a written description of patient selection criteria including referral arrangements for high-risk patientsrj (1 1) a copy of the contractual arrangements for the acquisition of the proposed cardiac catheterization equipment or cardiac angioplasty equipment, including itemization of the cost of the equipment; and (12) documentation that the cardiac catheterization equipment and cardiac angioplasty equipment and the procedures for operation of the equipment are designed and developed based on the American College of Cardiology/American Heart Association Guidelines for Cardiac Catheterization Laboratories (1991) report. Statutory Authority G.S. 131E-177(1). .1615 REQUIRED PERFORiMANCE STANDARDS (a) To be approved th e State Agency must 1030 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES determine The applicant shall demonstrate that the project is capable of meeting the following standards: (1) each proposed item of cardiac catheterization room equipment or cardiac angioplasty equipment, including mobile equipment wiH shall be utilized at an annual rate of at least 40 60 percent of capacity, measured during the fourth quarter of the third year following completion of the project; (2) if the facility applicant has— a compreh ensive oardiao s ervioea program—ef—the — proponent—intends proposes to perform elective — PTCA therapeutic cardiac catheterization procedures, each of the proponent applicant's therapeutic cardiac catheterization teams will be performing shall be performing at an annual rate of at least 50 PTCA 100 therapeutic cardiac catheterization procedures, measured during the fourth quarter of the third year of operation following completion of the project; (3) at least 50 percent of the projected cardiac catheterization procedures -wiH shall be performed on patients residing within the primary service area; (4) each existing item of cardiac catheterization room equipment and cardiac angioplasty equipment in each facility which has a primary service area that overlaps the proposed primary service area shall have been operated at a level of at least §0 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Facility Services; (5) the utilization of each existing or approved item of cardiac catheterization programs equipment and cardiac catheterization angioplasty equipment whose in each facility which has a primary service area that overlaps the proposed primary service area is not shall not be expected to fell below 40 60 percent of capacity due to the institution—of the — new or— e xpanded program acquisition of the proposed cardiac catheterization, cardiac angioplasty, or mobile equipment: (6) if the applicant proposes to perform diagnostic cardiac catheterization procedures, the applicant's—projected utilization and proposed staffing patterns are suoh that each diagnostic cardiac catheterization team -wiH shall be performing at an annual rate of at least 150 diagnostic-equivalent catheterization procedures by the end of the third year following completion of the projectT i (7) each item of existing mobile equipment in the proposed cardiac catheterization service area shall have been performing at least an average of four diagnostic-equivalent catheterization procedures per day per site in the proposed cardiac catheterization service area in the twelve month period preceding the submittal of the application; and (8) each item of existing or approved mobile equipment to be operating in the proposed cardiac catheterization service area shall be performing at least an average of four diagnostic-equivalent catheterization procedures per day per site in the proposed cardiac catheterization service area in the applicant's third year of operation. (b) If the proponent intends applicant proposes to perform pediatric cardiac catheterization procedures on patients age five and under, the State Agency must determine that the proponent the applicant shall demonstrate that it meets the following additional criteria: (1) the fecility has the capability to perform both pediatric diagnostic and therapeutic cardiac catheterization oervioes procedures and pediatric open heart surgery services on patients age five and under: (2) the proposed project wiH shall be performing at an annual rate of at least 80 150 pediatric cardiac catheterization procedures on patients age five or under during the fourth quarter of the third year following initiation of pediatric the proposed cardiac catheterization service for patients age five and under . (c) An applicant shall provide documentation of all assumptions and data used in the development of the projections required in this Rule. Statutory Authority G.S. 131E-177(1). 8:12 NORTH CAROLINA REGISTER September 15, 1993 1031 PROPOSED RULES .1616 REQUIRED SUPPORT SERVICES (a) If the proponent intendB applicant proposes to perform elective PH'CA therapeutic cardiac catheterization procedures, the State Agenoy must dotormino that the proponent the applicant shall demonstrate that hao aooooo to—aft open heart surgery services are provided within the same facility. (b) If the applicant proposes to perform diagnostic cardiac catheterization procedures, the applicant shall document that its patients will have access to a facility which provides open heart surgery services, in close proximity, and that the patients can be transported to that facility with no greater risk than if the procedure had been performed in a hospital which provides open heart surgery services. (c) (b) To be approved the State Agenoy must determine The applicant shall provide documentation to demonstrate that the following services wtH shall be available in the facility: (1) electrocardiography laboratory and testing services including stress testing and continuous cardiogram monitoring; (2) echocardiography service; (3) blood gas laboratory; (4) pulmonary function unit; (5) sfaffed blood bank; (6) hematology laboratory/coagulation laboratory; (7) microbiology laboratory; (8) clinical pathology laboratory with facilities for blood chemistry; 121 immediate endocardiac catheter (10) pacemaking jn case of cardiac arrest; and nuclear medicine services including nuclear cardiology. Statutory Authority G.S. I31E-177(l). .1617 REQUIRED STAFFING AND STAFF TRAINING (a) To be approved, th e State Agenoy must determine that the proponent The applicant shall provide documentation to demonstrate that eafl meet the following staffing requirements shall be met: (1) one physician licensed to practice medicine in North Carolina who has been designated to serve as director of the cardiac catheterization service and who has all of the following special credentials: (A) board-certified in internal medicine, (B) (C) pediatrics or radiology; subspecialty training aad — board eligibility' in cardiology, pediatric cardiology, or cardiovascular radiology; and current clinical experience in perform-ing physiologic procedures, angiographic procedures, or both; (2) at least one specialized team to perform cardiac catheterizations, composed of at least the following professional and technical personnel: (A) one physician licensed to practice medicine in North Carolina with evidence of special training and cur-rent experience in cardiovascular disease and radiation sciences; (B) one nurse with special training and current experience in critical care of cardiac patients, cardiovascular medi-cation, and catheterization equipment; and (C) at least three technicians with current specialized training in cardiac care who are capable of performing the duties of a radiologic technologist, cardiopulmonary technician, monitor-ing and recording technician, and darkroom technician. (b) To be approved, the State Agency must determine that th e proponent The applicant shall provide documentation to demonstrate that eon provide the following staff training shall be provid-ed for members of cardiac catheterization teams: (1) certification in cardiopulmonary resus-citation and advanced cardiac life sup-port; and (2) an organized program of staff education and training which is integral to the cardiac services program and ensures improvements in technique and the proper training of new personnel. Statutory' Authority G.S. 1 31 E- 1 77(1). .1618 DATA REPORTING REQUIREMENTS The facility must shall agree to provide^ upon the request of the Division of Facility Services, the following types of data and information to the Division of Facility Services , in accordance with data format and reporting requirements formulated by the Division of Facility Services: (1) demographic data on patients treated; (2) financial data; and (3) clinical data. 1032 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES Statutory Authority G.S. 131E-177(1). .1619 ACCESSIBILITY (a) The applicant shall provide documentation describing the mechanism that will be used to ensure that the projected number of medically underserved will be served in the facility. (h) The applicant shall provide written admissions policies identifying any prepayment or deposit requirements for the facility and stating the admission requirements for patients in each of the following payor categories: (1) Medicare; (2) Medicaid; (3) Blue Cross and Blue Shield; (4) Commercial Insurance; (5) State Employees Health Plan; (6) Self-Pay (includes self-pay, indigent and charity care); and (7) Other as identified by the applicant. (c) The applicant shall provide a written description of the billing procedures, including the credit and collection policies that will be utilized by the facility. (d) The applicant shall document that the health care community in the service area, including the Departments of Social Services and Health, have been invited to comment on the proposed project, particularly with regard to the facility's referral mechanisms and admissions policies for the medically underserved. Statutory Authority G.S I31E-I77(1). SECTION .1700 - CRITERIA AND STANDARDS FOR OPEN-HEART SURGERY SERVICES AND HEART-LUNG BYPASS MACHINES .1713 DEFINITIONS The following definitions -wtH shall apply to all rules in this Section: (1) "Capacity" of an open heart ourgioal ouite surgery room i s cons idered to be means 400 adult-equivalent open heart surgical procedures per year. One pediatric open heart surgical procedure on persons age 5 and under is valued at two adult open heart surgical procedures. For purposes of determining capacity, one open heart surgical procedure is defined to be one visit or trip by a patient to the open heart surgical suite surgery room for an open heart operation. (2) "Cardiac Surgical Intensive Care Unit" m-means a distinct intensive care unit as defined in 10 NCAC 3R .1213(2) and which is for exclusive use by post-surgical open heart patients. "Expanded—open—heart—surgical—suite " means the addition or oonveroion of an operating room to be dedicated for open heart surgical procedures. (3) "Heart-lung bypass machine is defined in G.S. 131E-176(10a). ^ "Pediatric open heart ourgioal procedure" means an open heart ourgioal procedure performed on a patient age five or under. (4) {9) " Open heart Service surgery service area" means a geographical area defined by the proponent applicant , which has boundaries that are not farther than 90 road miles from the facility. (5) "Open heart surgery services" is defined in G.S. 131E-176(18b). (6) (^ "Open heart surgical procedures" means are — highly—opeoializod—surgical prooedureo—which—utilize a heart lung bypaoo maohine (the "pump") to perform e xtra corpore al circulation etn4 oxygenation during surgery.—Open heart surgical procedureo include a wide range of procedures those surgical procedures which are identified by Diagnostic Related Group ("DRG") numbers 104, 105, 106, 107, and 108, and which are designed to correct congenital and acquired cardiac and coronary artery disease. £7} f4) "Open heart surgical suite surgery room " means an operating room dedicated to open heart surgical procedures^ which has been approved for this—use — by the — Certificate—ef — Need Section as reported on the most current hospital licensure application. , along with any related rooms used for preparation and immediate post operative recover)' of patients receiving an open heart surgical procedure. (8) (6) "Open heart surgical surgery program" includes means all of the open heart surgical—suites surgery rooms operated in one hospital. fT) "Percutaneous—trans luminal—coronary angioplasty (PTCA) procedure " means an interventional cardiac catheterization procedure used to treat coronary artery disease in which a balloon tipped catheter is placed in the diseased artery and then 8:12 NORTH CAROLINA REGISTER September 15, 1993 1033 PROPOSED RULES inflated to oompress the plaque blocking the arter>'. (9) {^ "Primary open heart surgery service area" means a geographical area defined by the proponent applicant , which has boundaries that are not ferther than 45 road miles from the facility. Statutory Authority G.S. 131E-177(1). .1714 INFORMATION REQUIRED OF APPLICANT (a) An applicant that proposes a—new—ef expanded to add an open heart surgiool—stHte surgery room or to acquire a heart-lung bypass machine must provide the information requested on shall use the acute care facility/medical equipment application form. (h) In addition to information requested on the aouto oare — application form, th e The applicant must shall also provide the following additional information: (1) the projected number of open heart surgical procedures to be completed in each open heart surgical suite surgery room and the projected number of open heart surgical procedures to be performed on each heart-lung bypass machine for each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used 4ef to make these projections; (2) the projected number of cardiac catheterization procedures to be completed in the facility for each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections; (3) the applicant's experience in treating cardiovascular patients at the facility during the past 12 months, including: (A) the number of patients receiving stress tests; (B) the number of patients receiving intravenous thrombolytic therapies; (C) the number of patients presenting in the Emergency Room or admitted to the hospital with suspected or diagnosed acute myocardial infarction; (D) the number of cardiac catheterization procedures performed, by type of procedure; (E) the number of patients referred to other facilities for cardiac catheterization or open heart sui^ical procedures, by type of procedure; (F) the number of patients referred to proponent's the applicant's facility for cardiac catheterization or open heart surgical procedures, by type of procedure; (4) the number of patients from the pro-posed open heart surgery service area who are projected to receive open heart surgical procedures by patient's county of residence in each of the first 12 quarters of operation for those projco tions including the methodology and assumptions used to make the projec-tions ; (5) the number of patients from the pro-posed primary open heart surgery ser-vice area who are projected to receive open heart surgical procedures by patient's county of residence in each of the first 12 quarters, including the methodology and assumptions used -fef to make these projections; (6) the projected patient referral sources ef patients ; (7) evidence of the applicant's capability to communicate efficiently with emergen-cy transportation agencies and with all hospitals serving the proposed service area; (8) the number and composition of open heart surgical teams available to the applicant; (9) a brief description of the applicant's in-service training or continuing education programs for open heart surgical team members; and (10) evidence of applicant's the capability to perform both cardiac catheterization and open heart surgical procedures en a 24 hours per day, 7 days per week Statutory Authority G.S 13IE-177(1). .1715 REQUIRED PERFORMANCE STANDARDS To be approved, th e State Agency must deter mine The applicant shall demonstrate that the proposed project is capable of meeting the follow-ing standardsTj^ (1) each open heart surgioal suite surgery room mii shall be utilized at an annual 1034 8:12 NORTH CAROLINA REGISTER September 15, 1993 PROPOSED RULES rate of at least 50 percent of capacity, measured during the fourth twelfth quar-ter of the third year following completion of the project; (2) the proponent will be performing a euffi oient number of applicant shall perform at least 4 diagnostic catheterizations te generate the proj ected—number of per open heart surgical procedures procedure during each quarter; 0) the proponent will be performing at an annual mto of at loaot 50 PTCA prooe duroD. measured during the fourth quarter of the third year following completion of the proj ect; (3) a new or additional heart-lung bypass machine shall be utilized at 200 open heart surgical procedures per year, mea-sured during the twelfth quarter following completion of the project; (4) at least 50 percent of the projected open heart surgical procedures wiU shall be performed on patients residing within the primary open heart surgery service area; (5) each existing open heart ourgioal suite surgery program in each facility which has a primary open heart surgery service area that overlaps the proposed primary open heart surgery service area operated at a level of a least 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Facility Services; (6) the utilization of existing open heart surgical surgery programs whose primary open heart surgery service area overlaps the proposed primary open heart surgery service area is not expected to fall below 50 percent of capacity due to the institu-tion of the new or expanded open heart surgical program; and surgery program; (7) the applicant's projected utilization and proposed staffing patterns are such that each open heart surgical team will be performing shall perform at an annual rate of at least 150 open heart surgical procedures by the end of the third year following completion of the proj ect. project; (8) the applicant shall document the assump-tions and provide data supporting the methodology used to make these projec-tions; and (9) heart-lung bypass machines that have been acquired for non-surgical use shall not be utilized in the performance of open heart surgical procedures. Statutory Authority G.S. 131 £-177(1). .1716 HOURS OF OPERATION To be approved, the State Agency must deter mine applicant shall demonstrate that the proponent has the capability of providing open heart surgical procedures—34 — houre—per day,—seven days—per week. Statutory Authority G.S. 1 31 E- 177(1). .1717 REQUIRED SUPPORT SERVICES (a) To be approved, the State Agency must determine The applicant shall demonstrate that the following services witt shall be available on a in the facility 24 hours per day, 7 days per week basis in the facility : (1) electrocardiography laboratory and testing services^ including stress testing and continuous cardiogram monitoring; (2) echocardiography service; (3) blood gas laboratory; (4) nuclear medicine laboratory; (5) pulmonary function unit; (6) staffed blood bank; (7) hematology laboratory or coagulation laboratory; (8) microbiology laboratory; (9) clinical pathology laboratory with facili-ties for blood chemistry; (10) dedicated cardiac surgical intensive care unit that shall be a distinct intensive care unit and shall meet the require-ments of 10 NCAC 3R .1200 ; (11) emergency room with full-time director, staffed for cardiac emergencies with acute coronary suspect surveillance area and voice communication linkage to the ambulance service and the coronary care unit; and (12) cardiac catheterization services includ-ing both diagnostic and interventional cardiac catheterization capabilities. (b) To be approved th e State Agency—mus t determine The applicant shall demonstrate that the following services 'mU shall be available to the proponent applicant : (1) a preventive mainten
Object Description
Description
Title | North Carolina register |
Date | 1993-09-15 |
Description | Vol. 8, issue 12 (September 15, 1993) |
Publisher | Raleigh, N.C. : Office of Administrative Hearings |
Digital Characteristics-A | 186 p.; 13.56 MB |
Digital Format | application/pdf |
Pres File Name-M | pubs_serial_ncregister19930915.pdf |
Pres Local File Path-M | \Preservation_content\StatePubs\pubs_serial_ncregister\images_master |
Full Text |
Re^/KF M/74-3^/.^2,//V(b7 \nclex: tab^e G
The
RECEIVED
'SEP i^ 1993
LAW LIBRARY
NORTH CAROLINA {±
REGISTER
IN TfflS ISSUE
EXECUTIVE ORDER
ITJTM
hriow y
PROPOSED RULES
Administration
Environment, Health, and Natural Resources
Human Resources
Insurance
Justice
Refrigeration Examiners
State Treasurer
Transportation
RRC OBJECTIONS
RULES INVALIDATED BY JUDICIAL DECISION
CONTESTED CASE DECISIONS
ISSUE DATE: September 15, 1993
Volume 8 • Issue 12 • Pages 1007 - 1184
INFORMATION ABOUT THE NORTH CAROLINA REGISTER AND ADMTNTSTRATTVE CODE
NORTH CAROLINA REGISTER TEMPORARY RULES
The North Carolina Register is published twice a month and
contains information relating to agency, executive, legislative and
judicial actions required by or affecting Chapter 150B of the
Genera] Statutes. All proposed administrative rules and notices of
public hearings filed under G.S. 150B-21.2 must be published in
the Register. The Register will typically comprise approximately
fifty pages per issue of legal text.
State law requires that a copy of each issue be provided free of
charge to each county in the state and to various state officials and
institutions.
The North Carolina Register is available by yearly subscription
at a cost of one hundred and five dollars (S105.00) for 24 issues.
Individual issues may be purchased for eight dollars (S8.00).
Requests for subscription to the North Carolina Register should
be directed to the Office of Administrative Hearings,
P. 0. Drawer 27447, Raleigh, N. C. 2761 1-7447.
Under certain emergency conditions, agencies may issue
temporary rules. Within 24 hours of submission to OAH, the
Codifier of Rules must review the agency's written statement of
findings of need for the temporary rule pursuant to the provisions in
G.S. 150B-21.1. If the Codifier determines that the findings meet
the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If
the Codifier determines that the fmdings do not meet the criteria,
the rule is returned to the agency. The agency may supplement its
findings and resubmit the temporary rule for an additional review
or the agency may respond that it will remain with its initial
position. The Codifier, thereafter, will enter the rule into the
NCAC. A temporary rule becomes effective either when the
Codifier of Rules enters the rule in the Code or on the sixth
business day after the agency resubmits the rule without change.
The temporary rule is in effect for the period specified in the rule or
180 days, whichever is less. An agency adopting a temporary rule
must begin rule-making procedures on the permanent rule at the
same time the temporary rule is filed with the Codifier.
ADOPTION AMENDMENT, AND REPEAL OF
RULES
NORTH CAROLINA ADMINISTRATIVE CODE
TTie following is a generalized statement of the procedures to be
followed for an agency to adopt, amend, or repeal a rule. For the
specific statutory authority, please consult Article 2A of Chapter
150B of the General Statutes.
Any agency intending to adopt, amend, or repeal a rule must
first publish notice of the proposed action in the North Carolina
Register. The notice must include the time and place of the public
hearing (or instructions on how a member of the public may request
a hearing); a statement of procedure for public comments; the text
of the proposed rule or the statement of subject matter; the reason
for the proposed action; a reference to the statutory authority for the
action and the proposed effective date.
Unless a specific statute provides otherwise, at least 15 days
must elapse following publication of the notice in the North
Carolina Register before the agency may conduct the public
hearing and at least 30 days must elapse before the agency can take
action on the proposed rule. An agency may not adopt a rule that
differs substantially from the proposed form published as part of
the public notice, until the adopted version has been published in
the North Carolina Register for an additional 30 day comment
period.
When final action is taken, the promulgating agency must file
the rule with the Rules Review Commission (RRC). After approval
by RRC, the adopted rule is filed with the Office of Administrative
Hearmgs (OAH).
A rule or amended rule generally becomes effective 5 business
days after the rule is filed with the Office of Administrative
Hearings for publication in the North Carolina Administrative Code
(NCAC).
Proposed action on rules may be withdrawn by the promulgatmg
agency at any time before final action is taken by the agency or
before filing with OAH for publication in the NCAC.
The North Carolina Administrative Code (NCAC) is a
compilation and index of the administrative rules of 25 state
agencies and 38 occupational licensing boards. The NCAC
comprises approximately 15,000 letter size, single spaced pages of
material of which approximately 35% of is changed annually.
Compilation and publication of the NCAC is mandated bv G.S.
150B-21.18.
The Code is divided into Titles and Chapters. Each state agency
is assigned a separate title which is further broken down by
chapters. Title 21 is designated for occupational licensing boards.
The NCAC is available in two formats.
(1) Single pages may be obtained at a minimum cost of
two dollars and 50 cents (S2.50) for 10 pages or less,
plus fifteen cents (50.15) per each additional page.
(2) The full publication consists of 53 volumes, totaling in
excess of 15.000 pages. It is supplemented monthly
with replacement pages. A one year subscription to the
full publication including supplements can be
purchased for seven hundred and fifty dollars
(S750.00). Individual volumes may also be purchased
with supplement service. Renewal subscriptions for
supplements to the initial publication are available.
Requests for pages of rules or volumes of the NCAC should be
directed to the Office of Administrative Hearings.
CITATION TO THE NORTH CAROLINA
REGISTER
The North Carolina Register is cited by volume, issue, page
number and date. 1:1 NCR 101-201, April 1, 1986 refers to
Volume 1, Issue 1, pages 101 through 201 of the North Carolina
Register issued on April 1, 1985.
FOR INFORMATION CONTACT: Office of
Administrative Hearings. ATTN: Rules Division, P.O.
Drawer 27447, Raleigh. North Carolina 27611-7447, (919)
733-2678.
NORTH
CAROLINA
REGISTER
Office of Administrative Hearings
P. O. Drawer 27447
Raleigh, North Carolina 27611-7447
(919) 733-2678
Julian Mann III,
Director
James R. Scarcella Sr.,
Deputy Director
Molly Masich,
Director ofAPA Services
Staff:
Ruby Creech,
Publications Coordinator
Teresa Kilpatrick,
Editorial Assistant
Jean Shirley,
Editorial Assistant
ISSUE CONTENTS
I. EXECUTIVE ORDER
Executive Order 23 1007
11. PROPOSED RULES
Administration
State Employees Combined
Campaign 1008
Environment, Health, and
Natural Resources
Health Services 1098
Human Resources
Facility Services 1014
Mental Health, Developmental
Disabilities and Substance Abuse
Services 1086
Social Services 1091
Insurance
Financial Evaluation Division . . . 1093
Life and Health Division 1094
Special Services Division 1096
Justice
Departmental Rules 1096
Licensing Board
Refrigeration Examiners 1148
State Treasurer
Retirement System 1146
Transportation
Motor Vehicles, Division of ... . 1145
III. RRC OBJECTIONS 1151
IV. RULES INVALIDATED BY
JUDICIAL DECISION 1155
V. CONTESTED CASE DECISIONS
Index to ALJ Decisions 1156
Text of Selected Decisions
92 OSP 1606 1163
93 HRC 0167 11^
93 CPS0205 1171
93 EHR0276 1176
VI. CUMULATIVE INDEX 1182
NORTH CAROLINA REGISTER
Publication Schedule
(July 1993 - May 1994)
Volume
and
Issue
Number
Issue
Date
Last Day
for
Filing
Last Day
for Elec-tromc
Filmg
Earliest
Date for
PubUc
Hearing
15 days
from
notice
* End of
Required
Comment
Penod
30 days
from
notice
Iflst Day
to Submit
to RRC
** Earliest
Effective
Date
8:7 07/01/93 06/10/93 06/17/93 07/16/93 08/02/93 08/20/93 10/01/93
8:8 07/15/93 06/23/93 06/30/93 07/30/93 08/16/93 08/20/93 10/01/93
8:9 08/02/93 07/12/93 07/19/93 08/17/93 09/01/93 09/20/93 11/01/93
8:10 08/16/93 07/26/93 08/02/93 08/31/93 09/15/93 09/20/93 11/01/93
8:11 09/01/93 08/11/93 08/18/93 09/16/93 10/01/93 10/20/93 12/01/93
8:12 09/15/93 08/24/93 08/31/93 09/30/93 10/15/93 10/20/93 12/01/93
8:13 10/01/93 09/10/93 09/17/93 10/18/93 11/01/93 11/22/93 01/04/94
8:14 10/15/93 09/24/93 10/01/93 11/01/93 11/15/93 11/22/93 01/04/94
8:15 11/01/93 10/11/93 10/18/93 11/16/93 12/01/93 12/20/93 02/01/94
8:16 11/15/93 10/22/93 10/29/93 11/30/93 12/15/93 12/20/93 02/01/94
8:17 12/01/93 11/05/93 11/15/93 12/16/93 01/03/94 01/20/94 03/01/94
8:18 12/15/93 11/24/93 12/01/93 12/30/93 01/14/94 01/20/94 03/01/94
8:19 01/03/94 12/08 '93 12/15/93 01/18/94 02/02/94 02/21/94 04/01/94
8:20 01/14/94 12/21/93 12/30/93 01/31/94 02/14/94 02/21/94 04/01/94
8:21 02/01/94 01/10/94 01/18/94 02/16/94 03/03/94 03/21/94 05/01/94
8:22 02/15/94 01/25/94 02/10/94 03/02/94 03/17/94 03/21/94 05/01/94
8:23 03/01/94 02/08/94 02/15/94 03/16/94 03/31/94 04/20/94 06/01/94
8:24 03/15/94 02/22/94 03/10/94 03/30/94 04/14/94 04/20/94 06/01/94
9:1 04/04/94 03/11/94 03/18/94 04/19/94 05/04/94 05/20/94 07/01/94
9:2 04/15/94 03/24/94 03/31/94 05/02/94 05/16/94 05/20/94 07/01/94
9:3 05/02/94 04/11/94 04/18/94 05/17/94 06/01/94 06/20/94 08/01/94
9:4 05/16/94 04/25/94 05/02/94 05/31/94 06/15/94 06/20'94 08/01/94
Note: Time is computed according to the Rules of Civil Procedure, Rule 6.
* An agency must accept comments for at least 30 days after the proposed text is published or until the date
of any public hearing, whichever is longer. See G.S. 150B-21. 2(f) for adoption procedures.
** The "Earliest Effective Date " is computed assuming that the agency follows the publication schedule above,
that the Rules Re\ie^v Commission approves the rule at the next calendar month meeting after submission, and
that RRC delivers the rule to the Codifier of Rules five (5j business days before the 1st business day of the next
calendar month.
Rexised 07/93
EXECUTIVE ORDER
EXECUTIVE ORDER NUMBER 23
PUBLIC SCHOOL ADMINISTRATOR
TASK FORCE
WHEREAS, this Administration has a goal of
doing more with less in our public schools by
increasing effectiveness and efficiency;
WHEREAS, business and industry leaders have
built up valuable expertise in using this strategy;
WHEREAS, the most effective and efficient ratio
of local public school administrators to teachers
and students is not icnown;
NOW, THEREFORE, by the power vested in me
as Governor by the Constitution and laws of North
Carolina, IT IS ORDERED:
Section 1. Recission of Executive Order.
Executive Order 12, dated May 12, 1993,
hereby rescinded.
IS
(b)
Section 2. Establishment.
There is hereby established a Public School
Administrator Task Force ("Task Force").
Section 3. Membership and Chair.
The Task Force shall consist of the following
members:
(a) twelve business and industry leaders with
experience in improving effectiveness and
efficiency in their organizations appointed
by the Governor;
nine representatives of the public school
system, appointed by the Governor,
consisting of: three superintendents,
three principals, and three teachers. A
small, medium, and large public school
system shall be represented in each cate-gory;
the Director of State Personnel, or his
designee;
the State Auditor, or his designee;
the Superintendent of Public Instruction,
or his designee; and
the State Budget Officer, or his designee.
(c)
(d)
(e)
(f)
school administrators to teachers and
students;
(b) Determine the ratio necessary to effec-tively
and efficiently administer quality
education at the local level;
(c) Develop guidelines for local public
school administrators to follow in imple-menting
more effective and efficient
administration; and
(d) Report its findings and recommendations
to the Joint Legislative Education Over-sight
Committee and to the State Board
of Education by May 1, 1994.
Section 5. Administration and Expenses.
The Task Force members shall be reimbursed for
reasonable travel and other expenses as allowed by
North Carolina law. Administrative and staff
support for the Task Force shall be principally
provided by the Office of the Governor. Addition-al
staff support may be provided by other state
agencies as required.
This order is effective immediately, and shall
terminate upon completion of the Task Force's
reported findings and recommendations.
Done in the Capital City of Raleigh, North
Carolina, this 26th day of August, 1993.
The chair shall be designated by the Governor,
and the Task Force shall meet at the call of the
Chair.
Section 4. Duties.
The Task Force shall have the following duties:
(a) Analyze existing ratios of local public
8:12 NORTH CAROLINA REGISTER September 15, 1993 1007
PROPOSED RULES
TITLE 1 - DEPARTMENfT OF
ADMINISTRATION
ISotice is hereby given in accordance with G.S.
150B-21.2 that the State Employees Combined
Campaign Advisory Committee intends to amend
rules cited as 1 NCAC 35 .0101 - .0103, .0201 -
.0204, .0301 - .0307 and repeal rule cited as 1
NCAC 35 . 0303. Existing Rules 1 NCAC 35 . 0301
- .0302, .0401 - .0407 are proposed to be recodi-fied
as .0203 - .0204, .0301 - .0307. This notice
reflects those recodification changes.
A he proposed effective date of this action is
December 1. 1993.
Ike public hearing will be conducted at 10:00
a.m. on October 4, 1993 at the State Library
Building, Room 211, 109 East Jones Street, Ra-leigh,
NC
ixeason for Proposed Action: To clarify and
consolidate rules applying to charitable organiza-tions
applying for inclusion in the State Employees
Combined Campaign.
i^omment Procedures: Written comments should
be submitted to: Secretary Betty Ray McCain,
Department of Cultural Resources, 109 East Jones
Street, Raleigh, NC 27603.
CHAPTER 35 - STATE EMPLOYEES
COMBINED CAMPAIGN
SECTION .0100 - PURPOSE AND
ORGANIZATION
.0101 DEFINITIONS
The puqjoso of the State Employees Combinod
Campaign ia to allow state employees the opportu
nity to contribute to charitable non partisan organ!
zations in an orderly and uniform process.—The
contributions are in turn granted to tho se charities
selected by the S.E.C.C. Advisory Committee.
These Regulations apply only to those campaigns
in which employees are asked to malce charitable
donations using payroll deduct ion as method of
payment.
(a) "Charitable organization." A non-partisan
organization that is tax-exempt for both the IRS
and N.C. tax purposes. The organization must
receive contributions that are tax deductible by the
donor.
(b) "Audit" or "audited financial statement." An
examination of financial statements of an organiza-tion
b^ a CPA. conducted in accordance with
generally accepted auditing standards, to determine
whether, in the CPAs opinion, the statements
conform with generally accepted accounting
principles or, if applicable, with another compre-hensive
basis of accounting.
(c) "State Employees Combined Campaign" or
"SECC. " The official name of the state employees
charitable fund-raising drive.
(d) "Federation" or "Federated Group" means a
group of voluntary charitable human health and
welfare agencies organized for purposes of supply-ing
common fund-raising, administrative, and
management services to its constituent members.
Statutory Authority G.S. 143-3.3; 143B-10.
.0102 PURPOSE
The official name of the state employoco charita
feie
—
fundmising—drive
—
te—tbe
—
State
—
Employees
Combined Campaign (SECC).
The purpose of the State Employees Combined
Campaign is to allow state employees the opportu-nity
to contribute to charitable non-partisan organi-zations
in an orderly and uniform process. The
contributions are in turn granted to those charities
selected by the SECC Advisory Committee. The
SECC is authorized to conduct a payroll deduction
fund-raising effort among state employees.
Statutory Authority G.S 143-3.3: 143B-10.
.0103 ORGANIZATION OF THE
CAMPAIGN
The Campaign Organization is as follows:
(I) Chair. Each year the governor Governor
may appoint a State Statewide Combined
Campaign Director Chair from one of the
Executive Cabinet^^ Council of State,
System of Community Colleges, or Uni-versity
Administration agencies. The
Campaign Director Chair or the Cam-paign
Director's Chair's designee will
serve as chair director of the campaign.
The responsibilities of the chair Chair
include setting the dates and approving
the published materials for the Combined
Campaign, contracting for the Statewide
Campaign Manager, and appointing and
serving as chair of the S.E.C.C. advisory
committee SECC Advisory Committee .
1008 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
For the purposes of selecting a Statewide
Campaign Manager, the Statewide Com-bined
Campaign Chair will consider the
following criteria:
(a) The organization must have demonstrat-ed
ability to manage large-scale fund-raising
campaigns.
(b) The organization must have the ability
and willingness to work with a state-wide
system of local organizations
capable of effectively managing local
combined campaigns and relating to the
Statewide Campaign Manager.
(c) The organization must have an accept-able
record of financial accountability.
(d) The organization must be a tax-exempt
organization under the Internal Revenue
Code.
(e) The organization must be willing and
able to provide a bond in an amount
satisfactory to the SECC Advisory
Committee to protect the participant
organizations and donors.
(2) SECC Advisory Committee. This ongo-ing
committee serves as a central applica-tion
point for all charitable organizations
applying to participate in the S.E.C.C.
SECC . The committee recommends
overall policy for the campaign to the
Governor, the Statewide Campaign ©i-reotor
Chair, and necessary state agencies
and recommends the criteria for partici-pation
by charitable organizations. The
committee reviews the recommendations
made by the Statewide Campaign Manag-er
and accepts or rejects its recommenda-tions.
The committee may, m its discre-tion,
require the Statewide Campaign
Manager to provide a bond, as provided
in Item (l)(e) of this Rule. The commit-tee
is composed of 10 state employee
members appointed by the Statewide
Campaign Director Chair. Members of
the committee will initially oervo stag
gorod torms of one, two, and three calen
dar years determined by the Campaign
Director.—As each member's term ex
pires,—tfee
—
replacement—members—wttt
serve a three year calendar appointment.
Members serve three-year staggered
terms at the pleasure of the Statewide
Campaign Chair. If a vacancy occurs,
the Statewide Campaign Chair shall
appoint a replacement to fill the unex-pired
term. Any member may be reap-pointed
at the end of his or her term.
(3) Statewide Campaign Manager. The
Statewide Campaign Manager is selected
by the Statewide Campaign Chair. The
duties of the Statewide Campaign Manag-er
include, but are not limited to. the
following:
(a) serving as the financial administrator of
the SECC;
(h) determining if the applicant agencies
meet the requirements of Rule .0202 of
this Chapter;
(c) submitting to the Statewide Campaign
Chair the name of an organization to
serve as Local Campaign Manager;
(d) providing the necessary supervision of
data processing services in order to
process all payroll deduction pledge
forms of state employees;
(e) receiving reports from the Local Cam-paign
Manager;
(f) transmitting to each Local Campaign
Manager its share of the state employ-ees
payroll deduction funds;
(g) printing and distributing the pledge
form, the campaign report form and
collection envelopes to the Local Cam-paign
Manager;
(h) maintaining an accounting of all funds
raised and submitting an interim unau-dited
end-of-campaign report of the
following:
(i) amounts contributed and pledged;
(ii) number of contributions; and
(iii) amounts distributed to each participat-ing
agency;
(i) Once applications for acceptance into
the campaign have been recommended
to the SECC Advisory Committee by
the Statewide Campaign Manager, a list
of all accepted organizations will be
prepared by the Statewide Campaign
Manager and distributed to all appli-cants.
Serves as the financial administrator for
th e Combmed Campaign and as such is
responsible for receiving reports from
the—leeal
—
Combined Campaigns,—fer
transmitting to each local campaign its
share of the state employees payroll
deduction funds, and for preparing an
end of campaign report which summa
rizes all fiscal campaign activity includ
ing local audits.—TTie Statewide Cam
paign Manager is also responsible for
8:12 NORTH CAROLINA REGISTER September 15, 1993 1009
PROPOSED RULES
tbe—printing—and
—
distribution—of the
pledge fonii. campaign report form,
and oolleotion envelopes.
(4) Local Campaign Chair. Tlie Governor,
if asked by the local charitable organiza-tions
accepted into the Combined Cam-paign,
may appoint an area representative
from either state government or the
University of North Carolina system to
serve as the looal chair Local Chair .
This person will be responsible for form-ing
a looal—advisory committee Local
Advisory Committee for recruitment of
volunteer state employeesT^ The Local
Chair and the Local Advisory Committee
are jointly responsible for the approval of
local campaign literature, the establish-ment
of local goals as needed, and the
distribution of any undesignated funds
made available for distribution.
(5) Local Campaign Manager. Onoe applioa
tions for acceptance into the campaign
have boon recommended to th e Commit
too by the Statewide Campaign Manager,
a list of all accepted organizations will be
prepared—by
—
the Statewide
—
Campaign
Manager and distributed to all applicants.
The State Campaign Manager will submit
to the State Combined Campaign Director
the name of an agency to serve as the
local campaign manager. The Campaign
Director Chair will approve or reject the
State Campaign Manager's recommenda-tion
and has the right to name the Local
Campaign Manager. The Local Cam-paign
Manager must identify itself on all
printed materials as the local manager of
the SECC rather than of any other orga-nization.
(a) For the purpose of selecting a Local
Campaign Manager, the Statewide
Campaign Chair and Statewide Cam-paign
Manager will consider the follow-ing
criteria:
(i) be a local organization willing to
conduct a local SECC;
(ii) comply with the terms of the
State/Local Managers contract;
(iii) have a broad base of community and
state employee support and volunteer
involvement;
(iv) have a demonstrated ability and suc-cessful
history of managing fund-raising
campaigns that include:
(A) development of campaign strate-
ID)
im
IE)
development of campaign materi-als;
development of volunteer cam-paign
structures;
training of volunteer solicitors;
have a financial structure and
resources that can efficiently
manage, account for, and disburse
funds;
be a participant organization of
the campaign;
must be able to develop financial
relationships with a network of
statewide organizations so as to
ensure the orderly transmittal,
disbursement, accounting of, and
reporting of donations and pledg-es.
fb) The local—manager Local Campaign
Manager is responsible for assisting the
Local Campaign Chair and Local Cam-paign
Advisory Committee in the print-ing
and distribution of campaign litera-ture,
the collection of pledge reports
and envelopes from the state agency
volunteers, the development of cam-paign
reports, and the forwarding of
one copy of each payroll deduction
pledge to the Statewide Campaign
Manager. In addition, an end of cam-paign
report shall be sent to the State-wide
Campaign Manager for inclusion
in the required fiscal reports.
(c) The Local Campaign Manager is re-sponsible
for the following:
(i) establishing an account with a bank in
order to receive deposits of collected
funds; and
(ii) distributing the funds from the contri-butions
in accordance with designa-tions
made by state employees. Un-designated
funds will be distributed
according to APA regulations govern-ing
the SECC.
Note: A contract between the state and the State-wide
Campaign Manager, and the state Statewide
and local manager Local Campaign Managers , will
be executed in order to develop an acceptable audit
trail. The contracts will allow a reasonable charge
for campaign expenses to be claimed by the State-wide
Campaign Manager and the local manager
Local Manager. All terms and conditions of these
contracts are subject to review and approval by the
Statewide Campaign Director Chair .
1010 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
Statutory Authority G.S. 143-3.3; 143B-10.
SECTION .0200 - APPLICATION PROCESS
AND SCHEDULE
.0201 APPLICATIONS
To be eligible to participate in the State Employ-ees
Combined Campaign, an organization must
apply annually for consideration, either as an
independent organization or as a group of organi
zations federation .
Statutory Authority G.S. 143-3.3; 143B-10.
.0202 CONTENT OF APPLICATIONS
(a) All organizations seeking inclusion in the
campaign must submit an application to the state
campaign. The application must include a com-pleted
State Employees Combined Campaign
Certificate of Compliance, provided by the State-wide
Campaign Manager. Included in or attached
to the Certificate of Compliance must be:
(1) A letter from the board of directors
requesting inclusion in the campaign.
(2) A complete description of services
provided, the service area of the orga-nization,
and fund-raising/administrative
costs.
(3) The most recent audited financial state-ment
prepared by a CPA within the
past two years. The year end of such
audited financial statement must be no
earlier than two years prior to the
current year's campaign date. The
SECC Advisory Committee may grant
an exception to this requirement if an
organization has filed its Articles of
Incorporation with the Secretary of
State's Oflice since March i of the
preceding year of the current campaign.
(4) A board statement of assurance of non-discrimination
of employment, board
membership and client services.
(5) A description of the origin, purpose and
structure of the organization.
(6) A list of the current members of the
board, including their addresses.
(7) A letter from the board of directors
certifying compliance with the eligibili-ty
standards listed in Paragraph (b) of
this Rule.
(8) When a federated fund-raising organiza-tion
submits an application they may
submit the credentials of the federation
only, not each member agency. By the
submission of such, the federations
certify that all of their member agencies
comply with all the SECC regulations,
unless there are exceptions. If there are
exceptions to the requirements, the
federations must disclose such and
explain to the satisfaction of the State-wide
Combined Campaign Advisory
Committee the reasons for the excep-tion,
(b) Organizations must meet the following
criteria to be accepted as participants in the Com-bined
Campaign:
(1) The organization must be licensed to
solicit funds in North Carolina if a
license is required by law .
(2) Have Must provide written proof of tax
exempt status for both the IRS federal
and N.C. tax purposes. Organizations
must certify that contributions from
state employees are tax deductible by
the donor under N.C. and federal law.
(3) Must prepare and make available to the
general public an annual audited finan-cial
statement. , report or IRS Form
99Gt The SECC Advisory Committee
may grant an exception to this require-ment
if an organization has filed its
Articles of Incorporation with the Sec-retary
of State's Office since March \
of the preceding year of the current
campaign. An exception to thi s ro
quirement is provided for any organiza
tion whioh—hoo filed its—Articles of
Inoorpomtion—with—the
—
Secretary—ef
State's Offico as of March 1, of the
preceding year of the current campaign.
(4) If fund-raising and administrative ex-penses
are in excess of 25 percent of
total revenue, the organization must
demonstrate to the satisfaction of the
SECC that those expenses for this
purpose are reasonable under all the
circumstances of the case.
(5) Must certify that all publicity and pro-motional
activities are truthful and non-deceptive
and that all material provided
to the SECC is truthful and non-decep-tive
.
(6) Must agree to maintain the confidential-ity
of the contributor list.
(7) Must permit no payments of commis-sions,
kickbacks, finders fees, percent-ages,
bonuses, or overrides for fund;
raising, and permit no paid solicitations
8:12 NORTH CAROLINA REGISTER September 15, 1993 1011
PROPOSED RULES
of the public.
(8) Must have a policy of non-discrimina-tion
on the basis of race, color, reli-gion,
sex, age, national origin or physi-cal
or mental handicap disability for
clients of the agency, employees of the
agency and members of the governing
board.
(9) Must provide benefits or services within
the local community, meaning that
employees in the solicitation area or
their femilies should be able to receive
benefits or services from the agency
within a reasonable distance , or receive
benefits—from—voluntary—agonoios .
Examples of services are include :
(a) (A) research and education in the
health and welfare or education fields;
(fe) £B} family and child care services;
{©) iC) protective services for children
and adults;
(4) (D) services for children and adults in
foster care;
^ £E} services related to the manage-ment
and maintenance of the home;
{^ £F} day care services for adults and
children;
(g) (G) transportation services, informa-tion
referral and counseling services;
(b) (H) the preparation and delivery of
meals;
(i) £1} adoption services;
{j) (J) emergency shelter care and relief
services;
{k) (K) safety services;
(i) £L) neighborhood and community
organization services;
(ffl) (M) recreation services;
(fi) (N) social adjustment and rehabilita-tion
services;
{e) £0} health support services; or
{p) ££} a combination of services de-signed
to meet the needs of special
groups such as the elderly or handi
capped disabled .
However, an international organization which
provides health and welfere services overseas,
whose activities do not require a local presence
and which meet other eligibility criteria, may be
accepted for participation in the campaign.
Statutory Authority G.S. 143-3.3; MSB-10.
tOMI .0203 SCHEDULE
Complete applications must be submitted to the
State Statewide Combined Campaign Advisory
Committee by February 15 annually to be included
in the fall campaign. Incomplete applications may
not be considered by the committee. The Chair
will forward all application materials to the State-wide
Campaign Manager within three working
days after the closing deadline. The Statewide
Campaign Manager will report to the Committee
its recommendation on each application within
three weeks of the closing deadline. The Commit-tee
shall affirm or reject each recommendation by
the Statewide Campaign Manager and will inform
the Statewide Campaign Manager of its decisions.
Statutory Authority G.S. 143-3.3; 143B-10.
.MQ2 .0204 RESPONSE
All applicants will be notified by the Statewide
Campaign Manager of the Committee's decision
within 50 45 days of the closing deadline. An
applicant who is dissatisfied with the determination
of its application may file an appeal to the State
Advisory Committee within 10 days of the notifi-cation
dispatch postmark date. An applicant who
is dissatisfied with either the committee's
Committee's decision or the appeal determination
of the committee Committee may commence a
contested case by filing a petition under 150B-23
within 60 days of notification dispatch postmark
date of the Committee's decision.
Statutory' Authority' G.S 143-3.3; 1438-10.
.0303
AH-FORM
AND CONTENT OF
APPLICATION
organizations seeking funding must submit an
application to th e state campaign. The application
must—include—the
—
State—Employees—Combined
Campaign Certificate of Compliance.—Included in
or attached to the Certificate of Compliance must
be-w-
-A etter—from—the
—
board—of directors
indicating interest.
(3) A complete description of services pro
vided. and th e s ervice area of th e organi
zntion.
{54 The most recent audited financial state
ment prepared by a CPA.—An exception
to this requireme nt is provided for any
organization which has filed its Articles
of Inoorpomtion with th e Secretary of
State's—Office
—
as of March—]-,—of th e
preceding year of the current campaign.
f4) A board stateme nt of assurance of non
discrimination.
1012 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
^^
m-f^
A desoription of tho origin, purpooe and
Btruoturo of the organization.
A list of the current members of the
board, including addresses.
A letter oortilying compliance with the
eligibility standards listed in Rule .0202
of this—Chapter—including—ta*
—
exempt
status, licensing, and showing the per
oentage of funds expended in the catego
ries of Program and Service, Manage
ment and General (Administrative) and
Fundmising.
Statutory Authority G.S. 143-3.3; 143B-10.
SECTION .MOO .0300 - GENERAL
PROVISIONS
.«401 .0301 OTHER SOLICITATION
PROfflBITED
Not more than one on-the-job solicitation for
funds will be made in any year at any location on
behalf of participating SECC agencies. The
prohibition does not include Red Cross sponsored
Bloodmobiles or employee association solicitations.
The State Employee Combined Campaign is the
only authorized payroll deduction fund raising
effort among state omployoos.
Payment may be made by payroll deduction,
cash, pledge, or personal check. If an employee
chooses to use the payroll deduction method of
contributing, he/she must agree to having have the
deduction continue for one year with equal
amounts being talcen deducted from each check
(monthly or biweekly depending on the payroll).
All deductions will start with the January payroll
and continue through December. If the employee
discontinues employment, or actively chooses to
discontinue payment, the state will not be responsi-ble
for the collection of the unpaid pledge. No
deduction will be made for any period in which the
employee's net pay, after all legal and previously
authorized deductions, is insufficient to cover the
allotment. No adjustments will be made in subse-quent
periods to make up for deductions missed.
Statutory Authority G.S 143-3.3; 143B-10.
t0404 .0304 CAMPAIGN LITERATURE
Each charitable organization accepted as a part of
the campaigUT must provide adequate information
about its servicesT including administrative/fund-raising
costs, to the local campaign manager Local
Campaign Manager for use in the local campaign.
Statutory Authority G.S 143-3.3; 143B-10.
Statutory Authority G.S 143-3.3; 143B-10.
t0403 .0302 COERCIVE ACTIVITIES
PROfflBITED
(a) In order to insure that donations are made on
a voluntary basis, actions that do not allow free
choice or that create an impression of required
giving are prohibited. Peer solicitation is encour-aged.
Employee Employees gifts are kept confi-dentialT^
except that employees may opt to have
their designated contributions acknowledged by the
recipient organizations.
(b) The following activities are not permitted:
(1) The Providing providing and using of
contributor lists for purposes other than
the routine collection^ and forwarding^
and acknowledgement of contributions.
(2) TTie establishment of personal dollar
goals or quotas.
(3) The developing and using of lists of
non-contributors.
Statutory Authority G.S. 143-3.3; 143B-10.
t0403 .0303 PAYMENT METHOD AND
TERMS OF CONTRIBUTION
t040S .0305 DESIGNATION CAMPAIGN
Each employee will be given the opportunity to
designate which agency or group of agencies
should benefit from his or her contribution to the
State Employees Combined Campaign. Each
employee will be given a listing list of the ap-proved
agencies in the campaign in order to help
them make the decision.
Statutory Authority G.S. 143-3.3; 143B-10.
.0406 .0306 DISTRIBUTION OF
UNDESIGNATED FUNDS
All contributions made through the S.E.C.C.
SECC should be designated to a particular recipi-ent.
Any monies not designated to a particular
recipient shall be deemed as undesignated funds.
Undesignated funds shall be allocated by the
S.E.C.C. SECC to the oounty/ local S.E.C.C.
SECC committees. The oounty/ local S.E.C.C.
SECC shall distribute these funds within their
communities.
Statutory Authority G.S. 143-3.3; 143B-10.
.0407 .0307 EFFECTIVE DATE OF
8:12 NORTH CAROLINA REGISTER September 15, 1993 1013
PROPOSED RULES
AMENDED RULES
These amended rules shall become offootivo ao
gpooified by statute and ohall apply to all applioa
tions—then
—
pending—or thereafter approved be
effective for the 1994 SECC and thereafter .
Statutory Authority G.S. 143-3.3; 143B-10.
TITLE 10 - DEPARTMENT OF
HUMAN RESOURCES
l\otice is hereby given in accordance with G.S.
150B-21.2 that the Division of Facility Services
intends to adopt rules cited as 10 NCAC 3R .0214,
.1213- .1219, .1413- .1419,. 1619, .1720. .1912
- .1918. .2120, .2314 - .2320, .2713 - .2719.
.3101 -.3108, .3201 - .3207, .3301 -.3306, .3401
- .3407, .3501 - .3507, .3601 - .3607. .3701 -
.3707. .3801 - .3807, .3901 - .3908, .4001 -
.4012, .4101 - .4107; amend rules cited as 10
NCAC 3R .0304. .0309. .0321, .1613 - .1618,
.1713 - .1715. .1717 - .1719, .2113 - .2119; and
repeal rules cited as 10 NCAC 3R .1202 - . 1209,
. 1402. . 1404 - . 1409, .1716, . 1902, . 1904 - . 1908,
.2702- .2707, .2710- .2711.
1 he proposed effective date of this action is
January- 4, 1994.
1 he public hearing will be conducted at 10:00
a.m. on October 29, 1993 at the Council Building,
Room 201. 701 Barbour Drive, Raleigh, North
Carolina 27603.
Keason for Proposed Action:
10 NCAC 3R .1202 - .1209, .1213 - .1219, .1617
.1619, .1716, .1720, .2120, 4101 - .4107 -
Repeal existing "intensive care service", "open
heart surgical services" rules and adopt rules
which would incorporate current medical practices
and technologies. Amend existing and establish
criteria and standards for review of CON applica-tions
for Pediatric Intensive Care Services, Cardi-ac
Catheterization Services and Ambulatory Sur-gery
Services.
10 NCAC 3R .1614, .1615 - .1616, .2115, .2117,
.2118 - To adopt as permanent rules amendments
to the temporary rules adopted effective September
1 , 1993, which amend existing criteria and stan-dards
for Cardiac Catheterization Services and
Ambulatory Surgical Services.
10 NCAC 3R .0214, .2314 - .2320, .3101 - .3108,
.3201 - .3207, .3301 - .3306, .3401 - .3407, .3501
- .3507, .3601 - .3607, .3701 - .3707, .3801 -
.3807, .3901 - .3908, .4001 - .4012 - To adopt as
permanent rules the temporary rules adopted
effective September 1 , 1993, which amend existing
and establishes criteria and standards pursuant to
Senate Bill 10 which was ratified on March 18,
1993.
10 NCAC 3R .1402, .1404 - .1409, .1413 - .1419,
.1902, .1904 - .1908, .1912 - .1918, .2702 -
.2707, .2710 - .2711, .2713 - .2719 - To repeal
existing rules and adopt as permanent rules the
temporary rules adopted effective September 1,
1993 which establishes criteria and standards
pursuant to Senate Bill 10 which was ratified on
March 18, 1993.
10 NCAC 3R .0304, .0309, .0321, .1613, .1713
- .1715, .1717 - .1719, .2113 .2114, .2116,
.2119 - To adopt as permanent rules the temporary
rules adopted September 1, 1993 which amends
existing and establishes criteria and standards
pursuant to Senate Bill 10 which was ratified on
March 18, 1993.
i^omment Procedures: All written comments must
be submitted to Jackie Sheppard, APA Coordina-tor,
Division of Facility Services, P. O. Box
29530. Raleigh, NC 27626-0530. telephone (919)
733-2342, up to and including October 29, 1993.
Written comments submitted after the deadline will
not be considered.
Auditor's Note: Temporary rules have been filed
effective September 1, 1993 with the exception of
Rules 10 NCAC 3R .1202 - .1209, .1213 - .1219,
.1617 - .1619, .1716, .1720, .2120 and .4101 -
.4107. The text of the temporary rules may differ
from the proposed permanent rules published in
this notice. The temporary rules can be obtained
by contacting the Office of Administrative Hear-ings,
Rules Division at (919) 733-2678.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3R - CERTIFICATE OF
NEED REGULATIONS
SECTION .0200 - EXEMPTIONS
.0214 REPLACEMENT EQUIPMENT
(a) The purpose of this Rule ]s to define the
terms used in the definition of "replacement
equipment" set forth in G.S. 131E-176(22a).
1014 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
(h) "Activities essential to acquiring and making
operational the replacement equipment" means
those activities which are indispensable and requi-site:
absent which the replacement equipment
could not be acquired or made operational.
(c) "Comparable medical equipment" means
equipment which is functionally similar and which
is used for the same diagnostic or treatment pur-poses.
(d) Replacement equipment is comparable to the
equipment being replaced if:
(1) il has the same basic technology as the
equipment currently in use, although it
may possess expanded capabilities due
to technological improvements; and
(2) it is functionally similar and is used for
the same diagnostic or treatment pur-poses
as the equipment currently in use
and is not used to provide a new health
service; and
(3) the acquisition of the equipment does
not result in more than a 10% increase
in patient charges or gsr procedure
operating expenses within the first
twelve months after the replacement
equipment is acquired; and
(4) it will be located on the same site or
campus as the equipment currently in
use.
(e) Replacement equipment is not comparable to
the equipment being replaced ifi
(1) the replacement equipment is new or
reconditioned, the existing equipment
was purchased second-hand, and the
replacement equipment is purchased
less than three years after the acquisi-tion
of the existing equipment; or
(2) the replacement equipment is new, the
existing equipment was reconditioned
when purchased, and the replacement
equipment is purchased less than three
years after the acquisition of the exist-ing
equipment; or
(3) the replacement equipment is perma-nently
fixed equipment and the existing
equipment is one piece of mobile equip-ment
which is shared between two or
more facilities.
(a) After receipt of a letter of intent, the agency
shall determine whether the proposed project
requires a certificate of need. In molcing this
deoiaion the agency shall consider th e obligation of
a capital expenditure on behalf of or for a health
service faoility to be :
(4^ an expenditure to bo obligated or in
ourred by the facility';
{3) an expenditure to be obligated or in
ourred by any person, board or organi
zation having ownership or control of
the faoility, or over which tho facility'
has ownership or control and which
relates to the provision of a hoalth
service;
0) an expenditure to bo obligated or in
ourred by any person, board or organi
zation with which the faoility has a
contractual relationship to provide or
purchase services, or share spaco, profit
or expenses—m—oonnootion—w4tfe—the
provision of a health service; or
(4) an expenditure to be obligated or in
ourred by any person, board or organi
zation developing a health service on
property owned or leased to or by the
faoility.
(b) If it is determined that the project requires a
certificate of need, the agency will determine the
appropriate review category or categories for the
proposed project, the type or types of application
forms to be submitted, the number of separate
applications to be submitted, the applicable review
period for each application, and the deadline date
for submitting each application.
(c) Copies of the application forms may be
obtained from the agency.
(d) Proposals requiring review will be reviewed
according to the categories and schedule set forth
in the duly adopted State Medical Facilities Plan in
effect at the time scheduled review period com-mences.
(e) Applications are competitive if they, in
whole or in part, are for the same or similar
services and the agency determines that the ap-proval
of one or more of the applications may
result in the denial of another application reviewed
in the same review period.
Statutory Authority G.S. 13] £-177(1). Statutory Authority G.S 131E-177; 131E-182.
SECTION .0300 - APPLICATION AND
REVIEW PROCESS
.0304 DETERMINATION OF REVIEW
.0309 REVIEW PERIOD
(a) The review of an application for a certificate
of need shall be completed within 90 days from the
beginning date of the review period for the appli-
8:12 NORTH CAROLINA REGISTER September 15, 1993 1015
PROPOSED RULES
cation, except as provided in Paragraph (b) of this
Rule.
(b) Except in the case of an expedited review,
Tb« the period for review may be extended for up
to 60 days by the agency if it determines that, for
one or more of the following reasons, it cannot
complete the review within 90 days:
(1) the extension is necessary to consider
conflicting, contradictory, or otherwise
relevant matters;
(2) the total number of applications
assigned to the project analyst for
review, including those in other review
periods, preclude the project analyst
from completing the review within 90
days;
(3) the complexity of the application or
applications to be reviewed make it
necessary to extend the review period;
(4) the review of an applicant's response to
the agency's request for additional
information has not been completed;
(5) the timing of the public hearing which
was held for the application or
applications under review does not
allow sufficient time to consider the
information presented;
(6) extension of previous reviews
necessitated that the project analyst
delay the commencement of the review;
or
(7) the unavailability of the project analyst
due to illness, annual leave, litigation
associated with other reviews, or other
duties and responsibilities.
(c) In the case of an expedited review, the
review period may be extended only if the Agency
has requested additional substantive information
from the applicant in accordance with G.S. 131E-
185(c).
(d) (e) Applicants will be provided written
notice of the extension of the review period after
the agency determines that an extension is
necessary. Failure to receive such notice prior to
the last day of the scheduled review period,
however, does not entitle an applicant to a
certificate of need nor authorize an applicant to
proceed with a project without one.
Statutory Authority G.S. 131E-177; 131E-185.
.0321 EXPEDITED REVIEW
(a) An applicant which desires an expedited
review shall submit a petition for an expedited
review with the Certificate of Need Section when
the application is submitted.
(b) The Certificate of Need Section shall review
the petition within 15 days from the beginning of
the review and shall notify the applicant if the
Agency has determined that a public hearing is in
the public interest.
(c) If the Certificate of Need Section decides
that it is not in the public interest to hold a public
hearing, a final determination on the request for an
expedited review shall not be issued until after the
thirty day written comment period has expired.
(dj If a request for a public hearing is received
by the Agency during the 30 day written comment
period, which is defined in G.S. 131E-185, the
request for an expedited review shall be denied.
(e) After the thirty day written comment period,
the Certificate of Need Section shall notify the
applicant that its petition for an expedited review
is approved or denied.
Statutory Authority G.S. 131E-177(1).
SECTION .1200 - CRITERIA AND
STANDARDS FOR INTENSIVE CARE
SERVICES
.1202 DEFINITIONS
TTie definitions in this Rule will apply to all rules
in this Section:
W- 4Ifntensive—eere those
—
services—means
sep.'ioes provided by an acute care caro
hospital te pati ents who require
continuous.—comprehensive
—
observation
and a high level of nursing core.
(3) "Intensive care unit" means a separate
self suffici ent—
e
ntity—within—which—aH-necessary
supplies and equipment
essential—te
—
provide
—
inte nsive—eare
services afe available—te pati e nts
requiring them.—This does not include
post op e rativ e r e covery rooms,
po s t delivery rooms. ef
—
emergency
observation unita.
Statutory Authority G.S 1 31 E- 177(1).
.1204 CAPACIT\ IN THE FACILITY AND
IN THE HEALTH SERVICE AREA
(e^
—
Proposals filed by or on behalf of hospital
faciliti es—fef
—
intensive—esfe
—
services—must—be
consistent with the applicable North Carolina State
Medical Facilities Plan, with th e applicabl e North
Carolina State Health Plan (the one in effect at
tifiw
of final—age ncy—decision)—aed—with—the
applicable h ealth systems plan.
1016 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
{b3 Propooalo—involving—new—ef
—
expanded
intonoivo oare bods must opeoif^' the numbero of
intensive oaro boda to bo operated following the
oompletion of the proposed project.
(e)
—
A proposal involving additional intensive
caro beds shall not be approved unless tho overall
as'omgo annual oooupanoy, over the
—
12 months
immediately—preceding—the
—
submittal—ef—the
proposal, of the total number of funotional existing
intensive oaro bods in the facility in which the
proposed beds are to bo operated i s at least 70
percent in unite with 20 or more intensive oare
bods, 65 percent in units with 10 19 intensive oare
bods, and 60 percent in units with 1 9 intensive
oare beds.
Statutory Authority G.S. 1 31 E- 177(1).
.1205 SCOPE OF SERVICES OFFERED
A proposal to provide new or expanded intensive
care services must document the extent to which
tho following will bo available.—If any item will
not be available, then substantive information must
bo given obviating tho need for that item before
approval for a nov'i ' or expanded service can be
given:
(4^ e
—
distinct,—identifiable—area—fef—the
provision of intensive care services ;
(S) twenty four hour on call availability of
laboratory and radiology services;
{i) 0;/air/suction capability;
(4) electronic cardiovascular monitoring
capability;
(§) capabilities for endotracheal intubation,
mechanical—ventilatory—assistance,—asd
oardiao pacemalcer insertion;
{6) oardiao arrest management plan;
f7) twenty four hour blood banlt.
Statutory Authority G.S. 131E-177(1).
.1206 PROJECTED UTILIZATION/
OCCUPANCY
(a)—A proposal to provide new or expanded
intensive care services must project an occupancy
level for the total intensive care services for each
of the first eight calendar quarters following the
oompletion of the proposed proj ect. An occupancy
level must also bo projected for each specialized
type of intensive care service to the extent that
specialized types of service are proposed to be
operated
.
—All assumptions, including the opooifio
methodologies by which occupancies are projected,
must be olearly stated.
•(b)
A proposal to provide new or expanded
intensive care services shall not be approved unless
oooupanoy is projected to be at least 75 percent for
the total number of intensive care beds proposed to
bo operated, no later than three years following the
oompletion—ef—the
—
proposed—project. AH
assumptions, including the specific methodologies
by
which—occupancies—are projected,—must—be
olearly stated.
(o) A proposal to establish a ne'.'. ' intensive oaro
or coronary oare unit shall not be approved unless
the utilization of tho unit is projected to be at least
at a rate of 4 b>eds at 75 percent occupancy no
later than throe years following the oompletion of
the proposed project.
Statutory Authority G.S. 131E-177(1).
.1207 PROJECTED PATIENT ORIGIN
(a)
—
A proposal to provide new or expanded
intensive care services must project patient origin
by
—
percentage—by
—
county—of residence. AH
assumptions, including the specific methodology
by whioh patient origin is projected, must be
clearly stated.
(b)
A proposal to provide new or expanded
intensive care services must show that at least 90
percent of the anticipated patient population is
within—45
—
minutes—automobile
—
driving—tiffle
(one way) from the facility, with the exception that
there
—
h*^"—be
—
variance
—
from—the—90
—
percent
standard for institutions traditionally offering very
specialized levels of intensive oare to a large and
geographically diverse population.
Statutory Authority G.S. 131E-177(1).
.1208 SITE AND EQUIPMENT
(a)
A proposal to provide new or expanded
intensive oare services must provide documentation
to shov/ that the services will be offered in a
phys ical—environment—that
—
conforms—te—the
requirements of federal, state, and local regulatory
bodies .
(fe)
A proposal to provide new or expanded
intensive care services must document the extent to
which—th«
following,—required—by—th«
—
Joint
Commiss ion on Accreditation of Hos pital s , will be
available.—If any item will not be available, then
substantive information must be given obviating
the need for that item before approval for a new or
expanded service can be given:
ft) oxygon—and
—
compressed—air and the
means of administration;
(3) mechanical ve ntilatory assistance
equipment—including airways,—manual
8:12 NORTH CAROLINA REGISTER September 15, 1993 1017
PROPOSED RULES
(^
breathing bag and ventilator/reopimtor;
oard i QO d e fibrillator with
synohronization capability;
(43 respiratory—afld
—
oardiao—monitoring
equipment;
(5^ thoranoentooio and closed thoroostomy
tmohoootomy sot;
toumiqucto;
f&3 vascular outdovvn oets;
(9) infusion pumps;
(+0) laryngoscopes and endotracheal tubes;
(44^ tracheobronchial—and
—
gastric—suction
equipment;
portable x my;
patient—weighing—device—fef—bed
patients.
Statutory Authority G.S. 131 £-177(1).
.1209 STAFFEVG
(e) A proposal—te
—
offer new—or expanded
intensive care services must provide documentation
to show that the appropriate t^'pes and numbers of
staff", particularly qualified medical and nursing
staff", will be available to support the services.
fb) A
—
proposal—te
offer—new—ef—
e
xpanded
intensive care services must provide documentation
to show that such services will be coordinated by
a registered nurse who—has formal training in
intensive care nursing.
Statutory Authority G.S 131 £-177(1).
.1213 DEFINITIONS
The definitions in this Rule shall apply to all
rules in this Section:
m "Intensive care services" means those
£2}
services provided by an acute care
hospital to patients with a wide variety of
illnesses of a life-threatening nature,
including patients with highly unstable
conditions which require so phisticated
medical and surgical intervention and a
high level of nursing care and those
patients which require continuous,
comprehensive observation.
"Intensive care unit" means a separate
self-sufficient entity which has all
supplies, equipment, and staff necessary
to offer intensive care services twenty-four
hours a day, seven days a week.
TTie term does not include post-operative
recovery rooms, post-delivery rooms, or
emergency observation units.
Statutory Authority G.S. 131 £-177(1).
.1214 INFORMATION REQUIRED OF
APPLICANT
(a) Applicant that proposes new or expanded
intensive care services shall use the Acute Care
Facility/Medical Equipment application form.
(b) Applicant proposing new or expanded inten-sive
care services shall also submit the following
additional information:
(1) the number of intensive care beds cur-rently
operated by the applicant and the
number of intensive care beds to be
operated following completion of the
proposed project;
(2) documentation of the applicant's experi-ence
in treating patients at the facility
during the past twelve months, includ-ing:
(A) the number of inpatient days of care
provided to intensive care patients;
(B) the number of patients initially treated
at the facility and referred to other
facilities for intensive care services;
and
(C) the number of patients initially treated
at other facilities and referred to the
applicant's facility for intensive care
services.
(3) the number of patients from the pro-posed
service area who are projected to
require intensive care services by the
patients' county of residence in each of
the first 12 quarters of operation, in-cluding
all assumptions and methodolo-gies;
(4) the projected number of patients to be
served and inpatient days of care to be
provided by county of residence by
specialized type of intensive care for
each of the first twelve calendar quar-ters
following completion of the pro-posed
project, including all assumptions
and methodologies;
(5) correspondence from the proposed
referral sources documenting their
intent to refer patients to the applicant's
facility;
(6) documentation which demonstrates the
applicant's capability to communicate
effectively with emergency transporta-tion
agencies,
(7) documentation of written policies and
procedures regarding the provision of
care within the intensive care unit.
1018 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
which includes, but js riot limited to the
following:
(A) the admission and discharge of pa-tients:
(B) infection control: and
(C) safety procedures;
(8) documentation that the proposed service
shall be operated in an area organized
as a physically and functionally distinct
entity, separate from the rest of the
facility, with controlled access;
(9) documentation to show that the services
shall be offered in a physical environ-ment
that conforms to the requirements
of federal, state, and local regulatory
bodies:
(10) a detailed floor plan of the proposed
area drawn to scale: and
(1 1) documentation of a means for observa-tion
by unit stafF of alj patients ]n the
unit from one vantage point.
Statutory Authority G.S. 131E-177(1}.
.1215 REQUIRED PERFORMANCE
STANDARDS
The applicant shall demonstrate that the proposed
project is capable of meeting the following stan-dards:
(1) the overall average annual occupancy rate
of all intensive care beds in the facility,
excluding neonatal and pediatric intensive
care beds, over the 12 months immediate-ly
preceding the submittal of the propos-al,
shall have been at least 70 percent for
facilities with 20 or more intensive care
beds, 65 percent for facilities with 10-19
intensive care beds, and 60 percent for
facilities with 1-9 intensive care beds;
(2) the projected occupancy rate for all inten-sive
care beds in the applicant's facility,
exclusive of neonatal and pediatric inten-sive
care beds, shall be at least 70 per-cent
for facilities with 20 or more inten-sive
care beds, 65 percent for facilities
with 10-19 intensive care beds, and 60
percent for facilities with 1-9 intensive
care beds, in the third operating year
following the completion of the proposed
project; and
(3) all assumptions and data supporting the
methodology by which the occupancy
rates are projected shall be provided.
Statutory Authority G.S. 131E-177(1).
.1216 REQUIRED SUPPORT SERVICES
(a) An applicant proposing new or additional
intensive care services shall document the extent to
which the following items are available:
(1) twenty-four hour on-call laboratory
services including microspecimen chem-istry
techniques and blood gas determi-nations;
(2) twenty-four hour on-call radiology
services, including portable radiological
equipment;
(3) twenty-four hour blood bank services:
(4) twenty-four hour on-call pharmacy
15} twenty-four hour on-call coverage by
respiratory therapy:
oxygen and air and suction capability;
electronic cardiovascular monitoring
capability:
mechanical ventilatory assistance equip-ment
including airways, manual breath-ing
bag and ventilator/respirator:
endotracheal intubation capability:
cardiac pacemaker insertion capability;
cardiac arrest management plan;
patient weighing device for bed
patients; and
isolation capability,
(b) If any item in Subparagraphs (a)(1) - (13) of
this Rule will not be available, the applicant shall
document the reason why the item is not needed
(61 m
18}
19}
(10)
ILQ
(12)
(13)
for the provision of the proposed services.
Statutory Authority G.S. 131E-177(1).
.1217 REQUIRED STAFFING AND STAFF
TRAINING
The applicant shall demonstrate the ability to
meet the following staffing requirements, in
accordance with recommendations and standards
from the Society of Critical Care Medicine for
intensive care units:
(1) nursing care shall be supervised by a
qualified registered nurse with specialized
training in the care of critically ill
patients, cardiovascular monitoring, and
life support;
(2) direction of the unit shall be provided by
a physician with training, experience and
expertise in critical care;
£3} assurance from the medical staff" that
twenty-four hour medical and surgical
on-call coverage is available: and
(4) appropriate inservice training or
continuing education programs shall be
8.12 NORTH CAROLINA REGISTER September 15, 1993 1019
PROPOSED RULES
provided for the intensive care staff.
Statutory Authority G.S. 131 £-177(1).
.1218 ACCESSIBILITY
(a) The applicant shall provide documentation
describing the mechanism that will be used to
insure that the projected number of medically
underserved will be served in the facility.
(b) The applicant shall provide written
admissions policies identifying any prepayment or
deposit requirements for the facility and
specifically stating the admission requirements for
patients in each of the following payor categories:
(1) Medicare;
(2) Medicaid;
(3) Blue Cross and Blue Shield;
(4) Commercial Insurance;
(5) State Employees Health Plan;
(6) Self-Pay (includes self-pay, indigent
and charity care); and
(7) Other as identified by the applicant.
(c) The applicant shall provide a written
description of the billing procedures, including the
credit and collection policies that will be utilized
by the facility.
(d) The applicant shall document that the health
care community in the service area, including the
Departments of Social Services and Health, have
been invited to comment on the proposed project,
particularly with regard to the facility's referral
mechanisms and admissions policies for the
medically underserved.
Statutory Authority G.S 131E-177(1).
.1219 DATA REPORTING REQUIREMENTS
The facility shall agree to provide, upon the
request of the Division of Facility Services, the
following types of data and information, in
accordance with data format and reporting
requirements formulated by the Division of
Facility Services:
(1) demographic data on patients treated;
(2) financial data; and
(3) clinical data.
Statutory Authority G.S. 131 £-177(1).
SECTION .1400 - CRITERIA AND
STANDARDS FOR NEONATAL SERVICES
.1402 DEFINITIONS
The definitions in this Rule will apply to all rules
in this Section:
(4^ "Normal newborn ocrvicoo" mcano those
routine Bervioes—provided by an acute
oare hospital to—normal fiill term -asd
normal pre term infante weighing at loost
2000 grams at birth. Routine oaro within
th+fi context includes increased
observation, screening, and otabilization
e#
—
infants—within—tbe—fi«t
—
ieuf—te
twenty four hours following birth.
"Neonatal—continuing—eaf=e
(3)- services"
m-means—
those—services—provided—by—aa
acute care hospital to low birth weight
infants who are not sick but who require
frequent feeding, infants who no longer
require neonatal intermediate eare
services—fetrt—wbe—stiH
—
require more
nursing hours than normal infants, and
infants who require close obsop>'ation for
any reason.
"Neonatal—intermediate—eafe
—
s ervices"
means those services—provided by an
acute care hospital to siok infants who do
not require neonatal intensive care but
who do—require six to twelve nursing
hours per day.
"Neonatal intensive care services" means
those services provided by an acute care
hospital—te
—
severely—iH
—
infants—wbe
require constant nursing care, as well as
continuous cardiopulmonary and other
supportive care.—Neonatal intensive care
difFers from neonatal intermediate care
with
—
regard—te—the
—
complexity'—&e
multiplicity' of patient problems, e.g. care
required for neonatal surgery' patients.
"Neonatal services"—means any of the
services defined in this Rule.
{4^
{§)-
Statutory Authority G. S 131E-1 77(1).
.1404 CAPACITY E^J THE FACILITY AND
ESf THE HEALTH SERVICE AREA
4a)
—
Proposals filed by or on behalf of hospital
facilities for neonatal services must be consiste nt
with the applicable North Carolina State Medical
Facilities Plan, with th e applicable North Carolina
State Health Plan (the one in effect at time of final
agency decision), and with the applicable health
systems plan.
{b) Proposals—involving—new
er—
e
xpanded
neonatal bassinets/beds must specify' the numbers
of neonatal bassinets/beds to be operated following
the completion of the proposed proj ect. Such
specification must be in terms of normal newborn
services.—neonatal—continuing—eafe
—
services.
1020 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
neonatal intermodiate ooro oorvioes, and neonatal
intonoivo oaro oorvioes. If lovela of oare other than
tbat—fep
—
normal—newborns—afe
—
involved,—tbe
proponont must define tho manner in whioh the
proponent deoignatoo beds for auoh lovelo.
•(e)
—
A proposal involving a net inoreose in the
tetal
number—of a—faoility's—existing—neonatal
intermediate oare beds and neonatal intensive oare
beds shall not be approved unless the overall
average annual oooupanoy,—over the
—
12 months
immediately—preceding—the
—
submittal—ef—the
proposal,—ef—th«
—
functional—existing—neonatal
intermediate care beds in the facility in whioh the
proposed beds are to bo operated is at least 8
percent.
4d) He—proposal—fer
—
additional—neonatal
intermediate care or neonatal intensive care beds
shall be approved unless it is determined that an
unmet need exists in the health service area or in
the proponent's defined service area in whioh the
proposed beds are to be operated. Need for
neonatal—intermediate—eare—beds—asd
—
neonatal
intensive care beds shall be computed for each of
the six established health service areas in North
Carolina by:
(4-) identifying the annual number of live
births occurring at all hospitals located
within the health service area, using the
latest available data compiled by the
Division of Health Services;
(3) identifying th e low birth weight rate
(percent—of live—births—below—2500
grams) for the births identified in (1) of
tbis
—
Subparagraph,—using—the
—
latest
available data compil ed by the Division
of Health Services;
f^ dividing—the—lew—bifth
—
weight—Fate
identified in (2) of this Subparagraph by
.08 and subsequently multiplying the
resulting quotient by four; and
{4) determining need for neonatal intensive
©are—beds—aed
—
neonatal—intermediate
oare beds in the h ealth service area as
the product of:
(A)
—
the product derived in—(3) of this
m-
Subparagraph, and
-the
—
quotient—resulting from—the
division of the number of live births
in the initial year of the projection
identified in (1) of this Subparagraph
by the number 1000.
Statutory Authority G.S. 131E-177(1).
.1405 SCOPE OF SERVICES OFFERED
{a)
—
A proposal to provide new normal newborn
services or neonatal continuing care services must
document the extent to which the following Vr'ill be
available.—If any item will not be available, then
substantive information must be given obviating
tho need for that item before appro^'al for a new or
expanded service can be given:
<4^ a
distinct,—identifiable—area
—
for tho
provision of the proposed service;
43) competence to manage uncomplicated
labor—asd
—
delivery—ef
—
normal—term
newborn;
4^) capability fef continuous fetal
monitoring;
(4) a
—
continuing—
e
ducation—program—ee
resuscitation—te
—
enhance—competence
among all delivery room personnel in
tb« immediate evaluation aft4
resuscitation of the newborn and of tho
mother;
(#) availability of obstetric services;
{6) capability for cesarean section within 30
minutes at any hour; and
f?) twenty four hour on call availability of
blood,—anesthesia—service,—radiology
service, clinical laboratory service.
(b)
—
A proposal to provide new or expanded
neonatal intermediate care services or neonatal
intensive care services must meet the requirements
of (a) of this Rule as well as document the extent
to whioh the following will be available.—If any
itofH—wiH—net—be
—
available,—then—
s
ubstantive
information must be given obviating the need for
that item before approval for a new or expanded
service can be given:
-a
k^ distinct,—identifiable—area—for—the
provision of th e proposed sorvioo;
{3) competence—te
—
manage
—
labor—and
delivery of premature newborns and
newborns with complications;
{5) twenty four hour coverage »f
microchemistry hematology and blood
gases;
f4) twenty four hour coverage by
respiratory therapy;
{5) twenty four hour coverage with
portable radiographic capability;
-Q;/air/suction capability';
6^ e lectronic cardiovascular ft»d
respiration monitoring capability;
48)- capabilities for endotracheal intubation
and meohanical ventilator^' assistance ;
oardio respirator^'—arrest—management
plan.
8:12 NORTH CAROLINA REGISTER September 15, 1993 1021
PROPOSED RULES
Statutory Authority G.S. 131E-177(1).
.1406 PROJECTED UTILIZATION/
OCCUPANCY
(a)
ProponentB proposing new normal newborn
and neonatal continuing oare oervioes must per
form, or projeot to perform, at looot 500 deliver
ioo, per year except that a varianoo from this
standard will be allowed to the extent that a sub
stantial portion of the population to be served
reside more than 45 minutes automobile driving
time (one vipy) from existing inpatient noonatol
servioeo.
{b)
A proposal to provide new normal newborn
or neonatal continuing oare oervioes. or new or
expanded interm ediate care oervioes or neonatal
intensive oare services , or any combination of the
four muot projeot an ocoupanoy level for each of
the services for each of the first eight calendar
quartero following the completion of the propooed
projeot.—All assumptions, including the speoifio
methodologies by whioh oooupancies are projected,
must be clearly stated.
{&)—A proposal to provide new normal newborn
and neonatal continuing care oervioes shall not be
approved—unless—for the total—number of beds
proposed to—be operated annual—occupancy—ts
projected to be 50 percent. Occupancy i o proj ected
to be 60 percent for a 1 10 bed unit, 65 percent
for a 11 20 bed unit. 70 percent for a 21 30 bed
unit, and 75 percent for a unit of 31 beds or more
after two years foUowmg the completion of the
proposed project.—All assumptions, including the
speoifio methodologies by whioh occupancies are
projected, must be clearly stated.
fd)
—
A proposal to provide new neonatal inter
mediate care services or new neonatal intensive
care services shall not be approved unless ocou
panoy is projected to be at least 75 percent for the
total number of neonatal intermediate care beds
and neonatal intensive oare beds proposed to be
operated, no later than three years following th e
completion of the propo sed projects.—All assump
tions,—mcluding—the specific—methodologi es—by
which occupancies are projected, must be clearly
stated
.
Statutory Authority G.S 131 E-1 77(1).
service by poroontage by oounty of residonoo.—AH
assumptions, including the speoifio methodology
by which patient origin is projootod.—must be
olearly stated.
{b)
—
A proposal to provide now normal newborn
or neonatal continuing care services must doou
ment that at least 90 percent of the anticipated
patient population is within 45 minutes driving
time (one way) from th e facility.
(e)
—
A proposal to provide now or expanded
neonatal—intermediate oare sorvioos—or new or
expanded neonatal—intensive care servicoo—mus t
document that at least 90 percent of tho anticipated
patient population is within 90 minutes driving
time (one v.oy) from the facility', with tho oxcop
tion that there may be a variance from the 90
percent standard for institutions with very special
ized levels of neonatal care to a largo and goo
graphically diverse population.
Statutory Authority G.S 131E-1 77(1).
.1408 SITE AND EQUIPMENT
A proposal to provide new or expanded neonatal
services must provide documentation to show that
the services will be ofiFered in a physical environ
ment that conforms to the requirement!) of federal,
state, and local regulator^' bodies.
Statutory Authority G.S 131E-177(1).
.1409 STAFFING
(a) A proposal to offer new or expanded ncona
tal services must provide documentation to show
that the appropriate types and numbers of staff,
particularly qualified medical and nursing staff",
will be available to support the servicoo.
{b)—A proposal to off^er new or expanded neona
tal intermediate care or neonatal intensive care
services must provide documentation to show that
such services will:
^4^ be coordinated by a registered nurse
who has completed an organized eduoa
tional program in neonatal intermediate
and intens ive care, and
(3) be under the direction of a physician
with training and experience in neonatal
intermediate and intensive care.
.1407 PROJECTED PATIENT ORIGIN
(a)
—
A proposal to provide new normal newborn
or neonatal continuing care services, or new or
expanded intermediate care services or neonatal
intensive care services, or any combination of th e
four must project patient origin for each proposed
Statutory Authority G.S 131 E-1 77(1).
.1413 DEFINITIONS
The definitions in this Rule shall apply to all
rules in this Section:
( 1) "Approved neonatal service" means a
1022 8:12 NORTH CAROLINA REGISTER September 15, 1993
PROPOSED RULES
I2i
i21
14}
15}
neonatal service that was not operational
prior to the beginning of the review
period but that had been issued a
certificate of need or for which
development had been initiated prior to
March 18. 1993 in accordance with G.S.
131E-175. et. al.
"Existing neonatal service" means a
16}
neonatal service in operation prior to the
beginning of the review period.
"High-risk obstetric patients" means
those patients requiring specialized
services provided by an acute care
hospital to the mother and fetus during
pregnancy, labor, delivery and to the
mother after delivery. The services are
characterized by specialized facilities and
staff for the intensive care and
management of high-risk maternal and
fetal patients before and during delivery.
"Level I neonatal service" means those
routine services provided by an acute
care hospital to normal full -term and pre-term
infants weighing at least 2000 grams
at birth. Level I neonatal services
include the observation, screening, and
stabilization of: infants following birth
who are served in a bassinet; infants who
are not sick but who require special care
and frequent feedings; infants who no
longer require Level II or Level III
neonatal services, but who still require
more nursing hours than normal infants;
and infants who require close observation
in a licensed acute care bed.
"Level II neonatal service" means the
performance of Level I neonatal services,
plus the management of high-risk, small,
and sick neonates with a moderate degree
of illness that are admitted within the
hospital or transferred from another
facility. Level II neonatal services
involve the management of newborns
weighing between approximately 1,500-
2,500 grams (or approximately 32 and
less than 36 completed weeks of
gestational age) that are relatively
healthy, or involve intermediate care
services for sick infants who do not
require intensive care but who do require
six to twelve nursing hours per day.
Level II neonatal services are provided in
a licensed acute care bed.
"Level III neonatal service" means the
performance of Level I and Level U
m
£8}
£9}
(10)
neonatal services plus the management of
high-risk newborns weighing less than
1,500 grams (or approximately under 32
weeks of gestational age), which requires
neonatal expertise. Level III neonates
require constant nursing care, including
but not limited to continuous
cardiopulmonary and other supportive
care, care required for neonatal surgery
patients and other intensive care services.
Level III neonatal services are provided
in a licensed acute care bed.
"Neonatal intensive care services" is
defined in G.S. I31E-I76(15b).
"Neonatal service area" means a
geographic area defined by the applicant
from which the patients to be admitted to
the service will originate.
"Neonatal services" means any of the
Level L Level II or Level III services
defined in this Rule.
"Obstetric services" means any normal or
high-risk services provided by an acute
care hospital to the mother and fetus
during pregnancy, labor, delivery and to
the mother after delivery.
"Perinatal services" means services
provided during the period shortly before
and after birth.
"Perinatal regions" mean a geographic
area of the state as established by the
Perinatal Council. A copy of the
perinatal regions may be obtained from
the Division of Maternal and Child
Health, Department of Environment,
Health and Natural Resources, 1330 St.
Mary's Street, Raleigh. NC. 27605-3248.
Statutory Authority G.S. 131E-177(1).
.1414 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant proposing to develop a new
neonatal service or to add a bed to an existing
neonatal service shall use the Acute Care
Facility/Medical Equipment application form.
(b) The applicant shall provide the following
additional information:
(1
)
the current number of Level I bassinets.
Level I beds. Level H beds and Level
III beds operated by the applicant;
(2) the proposed number of Level I
bassinets. Level I beds. Level H beds
and Level III beds to be operated
following completion of the proposed
nil
12}
8:12 NORTH CAROLINA REGISTER September 15, 1993 1023
PROPOSED RULES
project;
(3) evidence of the applicant's experience
in treating the following patients at the
facility during the past twelve months,
including:
(A) the number of obstetrical patients
treated at the acute care facility;
(B) the number of neonatal patients
treated in Level I bassinets. Level I
beds. Level II beds and Level III
beds, respectively;
(C) the number of inpatient days at the
facility provided to obstetrical
patients;
(D) the number of inpatient days provided
in Level I beds. Level U beds and
Level III beds, respectively;
(E) the number of high-nsk obstetrical
patients treated at the applicant's
facility and the number of high-risk
obstetrical patients referred from the
applicant's facility to other facilities
or programs; and
(F) the number of neonatal patients
referred to other facilities for
services, identified by required level
of neonatal service (i.e. Level ]_,
Level II or Level III);
(4) the projected number of neonatal
patients to be served identified by Level
L Level II and Level III neonatal
services and by county of residence for
each of the first twelve quarters of
operation following the completion of
the project, including the methodology
and assumptions used for the
projections;
(5) the projected utilization of the Level I
bassinets. Level I beds. Level H beds
and Level III beds, respectively, by
county of residence for each of the first
twelve quarters of operation following
completion of the project, including the
methodology and assumptions used for
the projections;
(6) if proposing to provide Level I neonatal
services, documentation that at least 90
percent of the anticipated patient
population is within 45 minutes driving
time one-way from the facility;
(7) if proposing to provide Level ] neonatal
services, documentation of a written
plan to transport infants to Level II or
Level III neonatal services as the
infant's care re |